Old Exam Questions

Question 1

In designing new medical devices one of the important processes is Quality Function Deployment (QFD), which is:

A. A process in which marketing investigates the ’voice of the customer’ in order to find out if the new medical device is profitable to produce.

B. A process in which ’the voice of the customer’ is heard first and then deployed and translated into technical issues through an orderly, four-phase process in which the product is planned, designed, made and then made consistently.

C. A process in which ’the voice of the developing engineers’ is heard and then deployed in order to answer the question of technical feasibility of the new medical device.

D. A process in which sales people investigate if customer and users will buy the new medical device.

E. A process in which the ’voice of the customer’ is heard first by marketing and then deployed in order to make sure that marketing understands the intended use of the new medical device.

Answer 1

B. A process in which ’the voice of the customer’ is heard first and then deployed and translated into technical issues through an orderly, four-phase process in which the product is planned, designed, made and then made
consistently.

Question 2

A medical device company, selling their product in the US, has an audit by an FDA auditor. Going through all the company’s documentation regarding developing the new product the auditor finds several documents regarding design requirements and the intended use of the device are missing. Is it OK if the company claims that:

A. The relevant document, for which the auditor is looking, has been lost because the company has moved recently to a new address.

B. The company had the relevant design requirements and intended to use the document on a computer file which unfortunately crashed.

C. An employee spilled coffee making the document not legible.

D. The company had an office fire in which the document was lost a couple of month ago.

E. None of the above. The manufacturer is at all times responsible to have a physical as well as an electronic backup of all relevant documents if they want to sell products in the US following FDA requirements.

Answer 2

E. None of the above. The manufacturer is at all times responsible to have a physical as well as an electronic backup of all relevant documents if they want to sell products in the US following FDA requirements.

Question 3

The Design History File (DHF) of a medical device product selling in the US is according to FDA regulation

A. A compilation of records which describes the design history of a prototype device necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of the Quality System Regulation of FDA.

B. A compilation of process documents which describes how the company develops medical devices in accordance with the approved design plans and the requirements of the Quality System Regulation of FDA.

C. A compilation of records which describes the design history of a finished device necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of the Quality System Regulation of FDA.

D. A file by which the finished developed device by R&D may be transferred to manufacturing in accordance with the approved design plans and the requirements of the Quality System Regulation of FDA.

E. A compilation of records which describes the design history of a similar device the company makes in order to demonstrate that the design of present product was similar and in accordance with the approved design plans and the requirements of the Quality System Regulation of FDA.

Answer 3

C. A compilation of records which describes the design history of a finished device necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of the Quality System Regulation of FDA.

Question 4

The Device Master Record (DMR) of a medical device product selling in the US is according to FDA regulation:

A. A compilation of those records containing the specification and procedures for a prototype medical device that is going to be produced on the manufacturing floor.

B. A document which contains device specifications including appropriate drawings, formulations, component specifications, and software specifications of a finished product.

C. A document which contains production process specifications including production procedures and methods as well as specification of production environments.

D. A document which contains quality assurance procedures and specifications including acceptance criteria for manufacturing equipment.

E. All of the above.

Answer 4

B. A document which contains device specifications including appropriate drawings, formulations, component specifications, and software specifications of a finished product.

Question 5

One method to express the failure rate of certain components of a medical device is to calculate the Mean Time Between Failure (MTBF) using the data of MIL-HDK-217 (US Military Handbook). In a given component case the failure rate is 0.25 failures/1 million hours what is the correct answer for MTBF in this case:

A. 4*10^6 hours

B. 2.5*10^6 hours

C. 4*10^6 failures

D. 40,000 failures

E. 2,500,000 hours

Answer 5

A. 4*10^6 hours

Question 6

Using active redundancy in comparison with using no redundancy for a given device component the Mean Time Between Failure (MTBF in hours) for that component is increased by:

A. 33%

B. 20%

C. 50%

D. 66%

E. 45%

Answer 6

C. 50%

Question 7

One method to address high failure rate of certain components of a medical device is the use of redundancy. Using active redundancy the formula for calculating component Mean Time Between Failure (MTBF in hours) is given by:

A. MTBF = 2/λ

B. MTBF = 3/2λ

C. MTBF = 1/λ

D. MTBF = 1/2λ

E. MTBF = 2/3λ

Answer 7

B. MTBF = 3/2λ

Question 8

Using standby passive redundancy in comparison with using active redundancy for a given device component the Mean Time Between Failure (MTBF in hours) for that component is increased by (assume example a failure rate of 0.25 per million hours):

A. 33%

B. 20%

C. 50%

D. 66%

E. 45%

Answer 8

A. 33%

Question 9

A structure in a medical device is required to withstand a mean pressure of 25,000 Pa. A safety margin of 1.0 is to be designed into the device. What is the pressure that must be designed in? :

A. 30,000 Pa

B. 5*10^4 Pa

C. 4*10^4 Pa

D. 40,000 psi

E. 4*10^4 kPa

Answer 9

B. 5*10^4 Pa

Question 10

Many medical device problems or failures are caused by user problems. What is the definition of the human factors approach in relation to developing new medical devices:

A. An application and database which keeps track of human user errors of finished products.

B. The process in which the user may complain of manufacturing regarding the design of a given medical device.

C. The application of fixing current problems of sold medical product errors and user errors.

D. The human factor is not an issue regarding good technical product solutions.

E. The application of the scientific knowledge of human capabilities and limitations to the design of systems and equipment to produce products with the most efficient, safe, effective, and reliable operation.

Answer 10

E. The application of the scientific knowledge of human capabilities and limitations to the design of systems and equipment to produce products with the most efficient, safe, effective, and reliable operation.

Question 11

In the human element in human factors engineering the following user issues are addressed:

A. Device memory: Long term and short term.

B. The sophistication of the device.

C. Engineering visual capability.

D. Device anthropometry.

E. None of the above.

Answer 11

E. None of the above.

Question 12

An exploratory prototype is:

A. An iterative prototype that is progressively refined until it becomes the final system

B. A prototype that explores the environmental conditions and human factors issues of the device.

C. A set of drawings that provide a static, non-computerized, non-working mock-up of user interface for the planned system.

D. A throw away prototype used to clarify project goals, to identify requirements, to examine alternative designs, or to investigate a large and complex system.

E. A prototype that may be used for field testing purposes to apply for a FDA 510k to market the product in the US.

Answer 12

D. A throw away prototype used to clarify project goals, to identify requirements, to examine alternative designs, or to investigate a large and complex system.

Question 13

In pre-market testing several issues given below is important to evaluate - which one is not?

A. Safety testing of the device.

B. Environmental conditions and human factors issues of the device.

C. Reliability and performance characteristics of the device.

D. Durability of the user of the device.

E. Software testing of the device.

Answer 13

D. Durability of the user of the device.

Question 14

In designing new medical devices one of the most important issues is the design input. Why?

A. Because it traces back to user and patient needs and intended use.

B. It communicates device requirements to product development team.

C. It outlines the requirements for verification.

D. It is the basis for ensuring proper functioning of the device.

E. All of the above.

Answer 14

E. All of the above.

Question 15

The design output of a medical device developing project consists of:

A. The total finished design output consists of the device itself, the device packaging and labeling, and the device master record (DMR).

B. The total finished design output consists of the device itself, its production specifications and labeling, and the device history record (DHR).

C. The total finished design output consists of the device itself, its packaging and labeling, and the device master report (MDR).

D. The total finished design output consists of the device itself, its packaging and labeling, and the device history file (DHF).

E. None of the above.

Answer 15

A. The total finished design output consists of the device itself, the device packaging and labeling, and the device master record (DMR).

Question 16

What do you understand by appropriate design reviews in FDA’s design control approach:

A. A process in which the R&D developing team evaluates and documents a comprehensive, systematic examination of the medical device design regarding the adequacy of design requirements, evaluates the capability of the design to meet design input requirements, and identifies problems.

B. A process in which ’the voice of the customer’ is first heard and then deployed and translated into technical issues through an orderly, four-phase process in which the product is planned, designed, made and then made consistently.

C. A process in which the developing engineers are discussing and reviewing technical component structure possibilities and cost reduction to meet competitive prices of a similar product on the market.

D. A process in which marketing and R&D people investigate if customer and users will buy the new medical device.

E. A process in which the marketing and sales teams evaluate and document a comprehensive, systematic examination of the medical device design regarding the adequacy of design requirements, evaluate the capability of the design to meet design input requirements, and identify problems regarding selling the device.

Answer 16

A. A process in which the R&D developing team evaluates and documents a comprehensive, systematic examination of the medical device design regarding the adequacy of design requirements, evaluates the capability of the design to meet design input requirements, and identifies problems.

Question 17

In designing and developing new medical devices risk management and analysis is very important because it reduces risk by:

A. Eliminating all risk of a medical device.

B. Provide safety mechanisms to protect patient and user.

C. Provide warning mechanisms and correct labeling to protect patient and user

D. Make risk of user and patient obvious in all critical clinical settings.

E. B and C are correct

Answer 17

E. B and C are correct

Question 18

Common methods for risk analysis include the following two “Top-Down” and “Bottom up” failure analysis methodologies:

A. Fault Tree Analysis (FTA) - Failure Mode and Effect Analysis (FMEA).

B. Fault Mode Analysis (FMA) - Failure Mode and Effect Analysis (FMEA).

C. Fault Records Analysis (FRA) - Failure Mode and Control Analysis (FMCA).

D. Fault Effect Analysis (FEA) - Failure Tree and Effect Analysis (FTEA).

E. None of the above.

Answer 18

A. Fault Tree Analysis (FTA) - Failure Mode and Effect Analysis (FMEA).

Question 19

In design control verification of a medical device means:

A. A confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Verification answers the question: “Did we design it right”.

B. A confirmation by examination and provision of objective evidence that design reviews have been successful. Verification answers the question: “Did we review the design correct?”.

C. A confirmation of user needs and intended use(s). Verification answers the question “Did we design the right device?”.

D. A confirmation of user needs and intended use(s). Verification answers the question “Did we design it right?”.

E. None of the above.

Answer 19

A. A confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Verification answers the question: “Did we design it right”.

Question 20

Design validation of a medical device means:

A. A confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Validation follows successful verification.

B. Testing by examination and provision of objective evidence that specified requirements have been fulfilled. Validation may follow unsuccessful verification.

C. A process by examination and provision of subjective evidence that specified requirements have been fulfilled. Verification may follow successful validation.

D. A confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Validation may follow unsuccessful verification.

E. A confirmation by examination and provision of objective evidence that specified requirements for a prototype device have been fulfilled. Validation may follow successful verification.

Answer 20

A. A confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Validation follows successful verification.

Question 21

According to FDA regulation a medical device classified as a Class III device is defined as:

A. A Class III device is one that is life sustaining but does not require a PMA.

B. A Class III device is one that does not sustain or support life so that its failure is not life threatening.

C. A Class III device is one for which standards or general controls provide reasonable assurance that the device is safe and effective.

D. A Class III device is one that that supports or sustains human life or is of substantial importance in preventing impairment of human health.

E. A Class III device is one that is sustaining life but not a health hazard.

Answer 21

D. A Class III device is one that that supports or sustains human life or is of substantial importance in preventing impairment of human health.

Question 22

FDA design control of medical device development projects does not apply to:

A. Research and feasibility studies of new medical devices.

B. Class II devices.

C. Class III devices.

D. Class IV devices.

E. All of the above.

Answer 22

A. Research and feasibility studies of new medical devices.

Question 23

FDA’s design control in the developing process includes:

A. Design input and design output and design review.

B. Design input and design verification and validation.

C. Risk analysis and design transfer.

D. Design changes.

E. All of the above.

Answer 23

E. All of the above.

Question 24

The most important patent of medical devices products are the utility patent and the design patent: What is the length of monopoly for those two types of patents?

A. 14 years and 14 years, respectively.

B. 14 years and 20 years, respectively.

C. 20 years and 14 years, respectively.

D. 20 years and 20 years, respectively.

E. 10 years and 14 years, respectively.

Answer 24

C. 20 years and 14 years, respectively.

Question 25

Safety of a device is concerned with: A. Failures that introduce hazards to the user or patient. B. Failures of a device to meet its requirements. C. Failures of a device that introduces unacceptable performance. D. Failures that introduce hazards to the users but not the patient. E. Failures that have no hazards to those using the instrument.

Answer 25

A. Failures that introduce hazards to the user or patient.

Question 26

Published values for reliability of a measuring medical device must include: A. The imprecision of the device. B. The systematic error of the device. C. Mean time to failure (MTF) and mean time between failure (MTBF). D. Mean time between two successful measuring events. E. Specifications of repeatability and reproducibility of the measuring device.

Answer 26

E. Specifications of repeatability and reproducibility of the measuring device.

Question 27

What is not an issue in the evaluation of a health hazard case and Corrective and Preventive Action (CAPA) of a given medical device?. A. Nonconformance of the product specifications. B. Competitive products are also failing with the same health hazard. C. A medical device report (MDR) must be filed with FDA if the evaluation uncover serious affects and health hazards to patients or using the instrument. D. A given corrective action must be tested if it really prevents the error of future production items. E. Evaluation includes an analysis of risk both to the patient and the user.

Answer 27

B. Competitive products are also failing with the same health hazard.

Question 28

In a US complaint case of a medical device measuring glucose a patient is seriously injured and dies because of getting too much insulin due to erroneous high glucose results readings on the device which were in reality too low (example measurements showed 12 mmol/L instead of 12 mg/dL). Technical investigations show that the software of the device had a bug regarding transmitting the unit of the result in certain combinations of keystrokes. The company should respond to this case by: A. Investigating this software case in order to make a corrective and preventive action and document it in the company’s file archive. B. Investigating this software case in order to make a corrective action and fix the problem in the next released version of the software. C. Investigate the case and make a corrective and preventive action to fix the bug and validate the fixing action. Make a FAN to all customers regarding the bug and the fix of the problem and file a medical device record (MDR) within 5 days with FDA. D. Investigating this software case in order to make a corrective and preventive action and document and fix test and test the fix and let the specific customers know how to fix the problem. E. The company must do both C and D.

Answer 28

C. Investigate the case and make a corrective and preventive action to fix the bug and validate the fixing action. Make a FAN to all customers regarding the bug and the fix of the problem and file a medical device record (MDR) within 5 days with FDA.

Question 29

In developing and selling medical devices in the US one of the following is not required by FDA regulations: A. Establish, maintain, and follow procedures to ensure that purchased products and services conform to specified requirements. B. Establish design control in the development process. C. Establish an automated production system as a part of commitment to product delivery on-time. D. Establish and maintain procedures for implementing corrective and preventive action regarding non-conformity of products. E. Establish a policy and objectives for a commitment to quality

Answer 29

C. Establish an automated production system as a part of commitment to product delivery on-time.

Question 30

The FDA Quality System Regulation has four important control sub-systems which FDA auditors very often tap into when they audit a manufacturer of medical devices. Which of the following is not included in these four subsystems? A. Design control. B. CAPA control. C. Financial control. D. Production and process control. E. Management control.

Answer 30

C. Financial control.

Question 31

The process of designing new medical devices is: ? A. A process in which biomedical engineers find out by Quality Function Deployment and knowledge regarding regulatory-/ financial- /health care-issues if a new technology is feasible. B. A process in which ’the voice of the customer’ is heard first and then deployed into important technical issues leading to a functional prototype which seem to have significant impact on the clinical care process in an IDE study in USA. C. To invent/improve/revise and formulate a plan for inventing/re-engineering/optimizing a medical device or system in relation to regulatory/financial/health care issues that addresses a significant clinical problem. D. To formulate the practical craftsmanship of producing medical new devices or systems in relation to regulatory/ financial /health care issues which addresses significant clinical. E. A process in which technical research as well as medical-/regulatory-/financial-/health care-issues play an important role.

Answer 31

C. To invent/improve/revise and formulate a plan for inventing/re-engineering/optimizing a medical device or system in relation to regulatory/financial/health care issues that addresses a significant clinical problem.

Question 32

A medical device developing plan involves many important issues to be addressed. Some are more important than others which of the following do you consider is addressed in a good medical device developing plan? A. Defining the business case and customer requirements and assessing the technical requirements and product options as well as designing developing and verifying the product. B. Sustain and monitor the product performance internally and at the end-user after launching it. C. Pilot manufacturing the product as well as validating the intended use internally and in customer field tests. D. Launching and commercializing the product as well as manufacturing the product full scale. E. All above are important issues to address.

Answer 32

E. All above are important issues to address.

Question 33

The Device Master Record (DMR) of a medical device product selling in the US contains is a record where to find the following information regarding specifications and procedures for a finished device being sold on the market Which of the following records do not belong to the DMR? A. Component specifications, design specifications, design validation results, packaging instructions. B. Component specifications, design specifications, design validation results C. Component specifications, design specifications, design validation results, quality assurance procedures of manufacturing, medical device reports (MDR’s) D. Component specifications, design specifications, design validation results, packaging instructions, product maintenance procedures E. Component specifications, design specifications, engineering drawings, design validation results.

Answer 33

C. Component specifications, design specifications, design validation results, quality assurance procedures of manufacturing, medical device reports (MDR’s)

Question 34

The Device History Record (DHR) of a medical device product selling in the US is according to FDA regulation: A. A record which contains component specifications, design specifications, design validation results, packaging instructions, product maintenance procedures B. A record of the device containing an assembly inspection record, dates of manufacturing, certificate of vendor compliance, field action report, field service report and Medical Device Reports (MDR). C. A record which contains production process specifications including production procedures and methods as well as specification of production environments. D. A record which contains quality assurance procedures and specifications including acceptance criteria for manufacturing equipment. E. All of the above.

Answer 34

B. A record of the device containing an assembly inspection record, dates of manufacturing, certificate of vendor compliance, field action report, field service report and Medical Device Reports (MDR).

Question 35

Using stand by redundancy in comparison with using no redundancy and active redundancy for device components the Mean Time Between Failure (MTBF in hours) is increased by: ? A. 33% and 100% B. 33% and 50% C. 100% and 50% D. 75% and 33% E. 100% and 33%

Answer 35

E. 100% and 33%

Question 36

An ECG device has a MTBF of 4000 hour. What is the failure rate (λ) using a stand by redundant component in the system: A. 5*10^-4 per hour B. 5*10^-3 per million hour C. 5*10^-4 per million hour D. 5*10^-5 per hour E. 5*10^-6 per hour

Answer 36

A. 5*10^-4 per hour

Question 37

Establishing tolerances for specific components of a device is an essential elements of assuring adequate medical device safety margins. In a given medical device a safety margin of 2,0 is required as a minimum for an important reliable valve construction. The valve should withstand a pressure of 100 mmHg. What is the pressure withstand that must be build into this valve? A. 300 kPa B. 150 mmHg C. 200 mmHg D. 100 mmHg E. 300 mmHg

Answer 37

E. 300 mmHg

Question 38

Anthropometry is an important approach and science that addresses several issues in developing new medical devices. Which of the following statements is addressed in the anthropometry? A. Making use of knowledge regarding human body and its parts in relation to functional capacities in a given practical use of a medical device. B. Generally design limits are based on a range of the 5th female to the 95th percentile male for critical body dimensions. C. Capabilities regarding one-hand and two-hand reaches in a given position. D. Strength capacity of the device operator considerations. E. All of the above

Answer 38

E. All of the above

Question 39

In the human element of human factors engineering the following user issues are addressed. Which one is not an element to be addressed? A. The human medical device interface B. Environmental issues regarding the medical device. C. Skills of the user of the medical device. D. The imprecision and inaccuracy of the device. E. Interaction between human elements of hardware and software

Answer 39

D. The imprecision and inaccuracy of the device.

Question 40

In pre-market field testing several issues given below is important to evaluate - which one is not? A. Application procedure testing using the device. B. Quality control procedures regarding the output of the device. C. Repeatability and reproducibility and performance characteristics of the device. D. Quality control of the user of the device. E. Software testing of the device.

Answer 40

D. Quality control of the user of the device.

Question 41

After developing and verifying as well a validating a given medical devices a Design Transfer document to full scale manufacturing is made. Which one of the following content do you consider not a part of this design transfer document? A. Service instructions B. Assembly drawings C. Workman specifications D. Inspection and test specifications E. Manufacturing instructions

Answer 41

A. Service instructions

Question 42

Which of the following statements is not an element of Design for Manufacturing (DFM) of a given medical device? A. Non-functional parts such as screws and fasteners. B. Reduce number functional parts. C. Reduce cost of components. D. Reduce the cost of supporting production E. Reduce marketing and selling costs

Answer 42

E. Reduce marketing and selling costs

Question 43

The FDA Quality System Regulation has seven important control sub-systems which FDA auditors very often tap into when they audit a manufacturer of medical devices. Which of the following control systems is included in these seven subsystems? A. Design Control and CAPA Control. B. Management Control and Material Control. C. Equipment Control and Facility Control D. Records, Documents and Change Controls E. All above.

Answer 43

E. All above.

Question 44

Design verification and design validation are important processes in biomedical product development. Which of the sentences below describes most accurately the purpose of the design verification and the design validation processes? A. Design verification is performed to ensure that the design specification meets user needs as expressed by voice of the customer. Design validation is performed to investigate product requirements in a clinical trial. B. Design verification is performed to confirm that design outputs meets design input requirements. Design validation is performed to ensure that the device design conforms to user needs and intended uses. C. Design verification is performed to confirm that a device design is feasible for manufacturing. Design validation is performed to confirm substantial equivalence with a predicate device. D. Design verification is performed to achieve an ISO 13485 certificate and a CE mark. Design validation is performed to ensure that the device design is ready for manufacturing

Answer 44

B. Design verification is performed to confirm that design outputs meets design input requirements. Design validation is performed to ensure that the device design conforms to user needs and intended uses.

Question 45

Medical devices must be CE marked before distribution in member states of the European Union (EU). Which of the sentences below describes most accurately the requirements to a CE marked medical device? A. A CE marked medical device must comply with the essential requirements of one of the EU medical device directives B. A CE marked medical device must comply with the essential requirements of one of the EU medical device directives and with the FDA’s 21CFR820 C. A CE marked medical device must comply with the essential requirements of all the EU medical device directives D. A CE marked medical device must comply with the essential requirements of the appropriate EU medical device directive

Answer 45

D. A CE marked medical device must comply with the essential requirements of the appropriate EU medical device directive

Question 46

The standard ISO 11608 “Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods” defines requirements and testing procedures applicable to e.g. insulin pen injectors. Which of the sentences below describes most accurately the ISO11608 standard? A. ISO 11608 is a harmonized horizontal standard B. ISO 11608 is a vertical standard C. ISO 11608 is a horizontal vertical standard D. ISO 11608 is a horizontal standard

Answer 46

B. ISO 11608 is a vertical standard

Question 47

Clinical evaluation is an essential requirement of the Active Medical Device Directive and of the Medical Device Directive. Which of the sentences below describes most accurately what a clinical evaluation is? A. A clinical evaluation must include both a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, and a critical evaluation of the results of all clinical investigations of the actual device. B. A clinical evaluation is a critical evaluation of a device to confirm that it meets the requirements of all relevant harmonized standards. C. A clinical evaluation is either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device or a critical evaluation of the results of all clinical investigations made. D. A clinical evaluation is a trial protocol approved by an ethical committee.

Answer 47

C. A clinical evaluation is either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device or a critical evaluation of the results of all clinical investigations made.

Question 48

Annex I of the Medical Device Directive (MDD) lists the essential requirements which must be met by medical devices regulated by the MDD. The first requirement states that: The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users etc. Which of the sentences below describes most accurately how to document that the first essential requirement of the MDD has been met? A. The Technical Documentation File (TDF) must contain a Project Risk Analysis. B. The Design History File (DHF) must contain a QFD analysis. C. The Technical Documentation File (TDF) must contain a Hazard Analysis. D. The Device History Record (DHR) must contain a Hazard Analysis.

Answer 48

C. The Technical Documentation File (TDF) must contain a Hazard Analysis.

Question 49

In an FMEA risk is assessed by analyzing potential failures down to component level. Which of the sentences below describes most accurately the parameters and their application in an FMEA? A. Severity (S), Occurrence (O) and Detection (D) are assessed and RPN = S+O+D is calculated. A high value of RPN (Risk Priority Number) indicates required action. B. Severity (S), Occurrence (O) and Detection (D) are assessed and RPN = S×O×D is calculated. A low value of RPN (Risk Priority Number) indicates required action. C. Severity (S), Occurrence (O) and Disregard (D) are assessed and RPN = S×O×D is calculated. A positive value of RPN (Recall Priority Number) indicates required action. D. Severity (S), Occurrence (O) and Detection (D) are assessed and RPN = S×O×D is calculated. A high value of RPN (Risk Priority Number) indicates required action.

Answer 49

D. Severity (S), Occurrence (O) and Detection (D) are assessed and RPN = S×O×D is calculated. A high value of RPN (Risk Priority Number) indicates required action.

Question 50

A company is developing a syringe with needle for the European and US markets. The syringe will be delivered with a protective cap to cover the needle before and after use. Early in the design phase, the company learns about complaints from users of a competitor product who have injured their fingers when applying a similar protective cap. Analysis reveals that the cap material can be penetrated by the needle. This penetration can only occur if the protective cap is not carefully aligned with the syringe when putting it on. Which of the sentences below describes most accurately what the company should do while developing their new product? A. The learning from the competitor product is used in the product risk analysis and the cap is designed using a material which can not be penetrated by the needle. B. The learning from the competitor product is used in the product risk analysis and the cap is designed such that the protective cap automatically aligns with the syringe when putting it on. C. The learning from the competitor product is used in the product risk analysis and the users manual carefully describes how to align the protective cap with the syringe when putting it on. The solution is validated and the result summarized in the DHF and the in the TDF. D. The learning from the competitor product is used in the product risk analysis and the cap is designed using a material which can not be penetrated by the needle. The solution is validated and the result summarized in the DHF and the in the TDF.

Answer 50

D. The learning from the competitor product is used in the product risk analysis and the cap is designed using a material which can not be penetrated by the needle. The solution is validated and the result summarized in the DHF and the in the TDF.

Question 51

The European standards bodies, CEN and Cenelec have the task of drawing up harmonised standards. Which of the sentences below describe most accurately the purpose of harmonised standards? A. Harmonised standards are technical specifications meeting the essential requirements of the directives, compliance with which will provide a presumption of conformity with the essential requirements. B. Harmonised standards are technical specifications meeting the particular requirements of the directives, compliance with which will provide a presumption of conformity with the essential requirements. C. Harmonised standards are the essential requirements of the directives. D. Harmonised standards are vertical specifications meeting the essential requirements of the directives, compliance with which will provide a presumption of conformity with the essential requirements.

Answer 51

A. Harmonised standards are technical specifications meeting the essential requirements of the directives, compliance with which will provide a presumption of conformity with the essential requirements.

Question 52

Diabetic nephropathy is suspected when a urinalysis of a person with diabetes shows too much protein in the urine (albuminuria). A company is developing an albuminuria test system including a SW controlled electronic meter for the European and US markets. Which of the sentences below describe most accurately the regulatory requirements relevant to the product development? A. The product should meet the requirements of the In Vitro Diagnostic Medical Devices Directive and the design control requirements of the FDA 21CFR820 Quality System Regulation B. The product should meet the requirements of the Medical Devices Directive and the requirements of the FDA 21CFR822 Investigational Device Exemptions C. The product should meet the requirements of the Active Implantable Medical Devices Directive and the design control requirements of the FDA 21CFR820 Quality System Regulation D. The product should meet the requirements of the In Vitro Diagnostic Medical Devices Directive and the requirements of the FDA 21CFR822 Investigational Device Exemptions

Answer 52

A. The product should meet the requirements of the In Vitro Diagnostic Medical Devices Directive and the design control requirements of the FDA 21CFR820 Quality System Regulation

Question 53

Which of the statements below describes most accurately what is required for an invention to be patentable? A. The invention must be new, non-obtrusive and industrially useful B. The invention must be new, non-obvious and industrially useful C. The invention must be new, non-obtrusive and environmentally acceptable D. The invention must be new, non-obvious and environmentally acceptable

Answer 53

B. The invention must be new, non-obvious and industrially useful

Question 54

A testing laboratory is equipped with 12 test benches for testing blood pressures monitors. The performance of a newly developed blood pressure monitor product is tested for 1000 hours using all 12 test benches.. During the testing the monitors on bench 2 and 6 fail and are replaced with new monitors. On test bench 11 the blood pressure monitor must be replaced twice because of failures. Which of the calculations below describes most accurately the correct estimate of the failure rate? A. λ = 3/(1000 hours*12) = 250 failures per million hours B. λ = (1000 hours*12)/4 = 3000 hours C. λ = 4/(1000 hours*12) = 333 failures per million hours D. λ = 2/(1000 hours*12) = 667 failures per million hours

Answer 54

C. λ = 4/(1000 hours*12) = 333 failures per million hours

Question 55

A testing laboratory is equipped with 12 test benches for testing blood pressure monitors. The performance of a newly developed blood pressure monitor product is tested for 1000 hours using all 12 test benches. During the testing none of the monitors fail. Which of the statements below describes most accurately the mean time between failures? (You may or may not want to know that Χ^2_(0,05;2) = 6, (chi square, risk level 5%, 2 degrees of freedom) A. MTBF > 4000 hours with 95% probability B. MTBF > 12000 hours with 95% probability C. MTBF > 24000 hours with 95% probability D. MTBF > 40000 hours with 95% probability

Answer 55

A. MTBF > 4000 hours with 95% probability

Question 56

The failure rate of a medical device may be expressed by the Mean Time Between Failures (MTBF). The failure rate of a pulse oximeter has been estimated to be lower than 20 failures per million hours operating time. Which of the statements below describes most accurately the MTBF of the pulse oximeter? A. MTBF < 20000 hours B. MTBF < 50000 hours C. MTBF > 50000 hours D. MTBF > 200000 hours

Answer 56

C. MTBF > 50000 hours

Question 57

The design output of a medical device development project consists of a number of items. Which of the statements below describes most accurately the final design output? A. The total finished design output consists of the device itself, the device packaging and labeling, and the Device Master Record (DMR). B. The total finished design output consists of the device itself, its production specifications and labeling, and the device history record (DHR). C. The total finished design output consists of the device itself, its packaging and labeling, and the device master report (MDR). D. The total finished design output consists of the device itself, its packaging and labeling, and the device history file (DHF).

Answer 57

A. The total finished design output consists of the device itself, the device packaging and labeling, and the Device Master Record (DMR).

Question 58

A company wants to perform a clinical investigation in Denmark of a medical device under development. Which of the statements below describes most accurately what is required? A. The clinical investigation requires authorisation from the Danish Medicines Agency (Lægemiddelstyrelsen, LMS) and the Scientific Ethical Committee must approve the investigation. B. The clinical investigation only requires that the Scientific Ethical Committee approves the investigation. C. The clinical investigation only requires authorisation from the Danish Medicines Agency (Lægemiddelstyrelsen, LMS) D. The clinical investigation requires authorisation from the Danish Medicines Agency (Lægemiddelstyrelsen, LMS) and CE marking by a Notified Body (NB)

Answer 58

A. The clinical investigation requires authorisation from the Danish Medicines Agency (Lægemiddelstyrelsen, LMS) and the Scientific Ethical Committee must approve the investigation.

Question 59

Which of the statements below describes most accurately the purpose of Quality Function Deployment (QFD)? A. The QFD process begins with the wants of the customer. The QFD process provides a means of prioritizing design trade-offs, to track product features against competitive products, and to select the best manufacturing process to optimize product features. B. The QFD process begins with the wants of the customer. The QFD process provides a means of prioritizing risks, to track product features against competitive products, and to select the best manufacturing process to optimize product features. C. The QFD process begins with the wants of the customer. The QFD process provides a means of prioritizing design trade-offs, to ensure IP protection, and to select the best manufacturing process to optimize product features. D. The QFD process begins with the wants of the customer. The QFD process provides a means of prioritizing design trade-offs, to track product features against competitive products, and to document design transfer.

Answer 59

A. The QFD process begins with the wants of the customer. The QFD process provides a means of prioritizing design trade-offs, to track product features against competitive products, and to select the best manufacturing process to optimize product features.

Question 60

A 510(k) requires demonstration of substantial equivalence of a medical device to another legally U.S. marketed device (the predicate device). Which of the statements below describes most accurately what substantial equivalence means? A. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it has the same intended use as the predicate; and has the same technological characteristics as the predicate; or has different technological characteristics and the information submitted to FDA 1) raises new questions of safety and effectiveness; and 2) demonstrates that the device is almost as safe and effective as the legally marketed device (always clinical data). B. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it has the same intended use as the predicate; or has the same technological characteristics as the predicate. C. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it has the same intended use as the predicate; and has the same technological characteristics as the predicate; or has different technological characteristics and the information submitted to FDA 1) does not raise new questions of safety and effectiveness; and 2) demonstrates that the device is at least as safe and effective as the legally marketed device (not always clinical data). D. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it has the same intended use as the predicate; or has different technological characteristics and the information submitted to FDA 1) does not raise new questions of safety and effectiveness; and 2) demonstrates that the device is at least as safe and effective as the legally marketed device (not always clinical data).

Answer 60

C. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it has the same intended use as the predicate; and has the same technological characteristics as the predicate; or has different technological characteristics and the information submitted to FDA 1) does not raise new questions of safety and effectiveness; and 2) demonstrates that the device is at least as safe and effective as the legally marketed device (not always clinical data).

Question 61

A company wants to test the performance of an electronic injection pen in a clinical trial in collaboration with two hospitals in the EU. Which of the sentences below describes most accurately the minimum requirements which the electronic injection pen must satisfy? A. The electronic injection pen must comply with the essential requirements of the EU Medical Device Directive B. The electronic injection pen must comply with the essential requirements of the EU Active Implantable Medical Device Directive C. The electronic injection pen must be CE marked and meet the essential requirements of the EU Medical Device Directive D. The electronic injection pen must comply with the essential requirements of the EU Medical Device Directive and be approved by a Notified Body

Answer 61

A. The electronic injection pen must comply with the essential requirements of the EU Medical Device Directive

Question 62

Fitt’s law is a model of human movement primarily used in human–computer interaction and ergonomics that predicts that the time required to rapidly move to a target area is a function of the distance to the target and the size of the target. Fitt’s law can be formulated as: T=a+b*log_2(1+D/W) Which of the sentences below describes most accurately the parameters of Fitt’s law as stated above? A. T is the average time taken to complete the movement, a represents the start/stop time of the device (intercept) and b stands for the inherent speed of the device (slope), D is the distance from the starting point to the center of the target, W is the width of the target measured along the axis of motion B. T is the probability of hitting the target, a represents the start/stop time of the device (intercept) and b stands for the inherent speed of the device (slope), D is the distance from the starting point to the center of the target, W is the width of the target measured along the axis of motion C. T is the average time taken to complete the movement, a represents the start/stop time of the device (intercept) and b stands for the inherent speed of the device (slope), D is the distance from the edge to the center of the target, W is the width of the target measured along the axis of motion D. T is the average time taken to complete the movement, a represents the start/stop time of the device (intercept) and b stands for the inherent speed of the device (slope), D is the distance from the starting point to the center of the target, W is the width of the movement measured along the axis of motion

Answer 62

A. T is the average time taken to complete the movement, a represents the start/stop time of the device (intercept) and b stands for the inherent speed of the device (slope), D is the distance from the starting point to the center of the target, W is the width of the target measured along the axis of motion

Question 63

Failure Mode and Effect Analysis (FMEA) and Fault Tree Analysis (FTA) are tools applied in product development to identify potential product or process failures. Which of the sentences below describes most accurately the FMEA and FTA tools? A. FMEA is a top down, deductive failure analysis in which an undesired state of a system is analyzed using boolean logic to combine a series of lower-level events. FTA is a bottom up, failure analysis to identify and characterize risks in terms of severity, probability and detectability. B. FTA is a bottom up, deductive failure analysis in which an undesired state of a system is analyzed using boolean logic to combine a series of lower-level events. FMEA is a top down, failure analysis to identify and characterize risks in terms of severity, probability and detectability. C. FTA is a top down, deductive failure analysis in which an undesired state of a system is analyzed using boolean logic to combine a series of lower-level events. FMEA is a bottom up, failure analysis to identify and characterize risks in terms of severity, probability and detectability. D. FMEA is a bottom up, deductive failure analysis in which an undesired state of a system is analyzed using boolean logic to combine a series of lower-level events. FTA is a top down, failure analysis to identify and characterize risks in terms of severity, probability and detectability.

Answer 63

C. FTA is a top down, deductive failure analysis in which an undesired state of a system is analyzed using boolean logic to combine a series of lower-level events. FMEA is a bottom up, failure analysis to identify and characterize risks in terms of severity, probability and detectability.

Question 64

FDA requires formal design reviews as part of design control for medical devices. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. Which of the sentences below describe most accurately the formal design reviews? A. Formal design reviews a) are a systematic assessment of design results to provide feedback to designers on existing or emerging problems b) are performed by representatives for all involved in the design plus specialists without direct responsibility for the design being reviewed B. Formal design reviews a) are a systematic assessment of design results to provide feedback to designers on existing or emerging problems b) are performed by representatives for all involved in the design plus management representatives without direct responsibility for the design being reviewed C. Formal design reviews a) are a systematic assessment of design results to provide feedback to designers on existing or emerging problems b) are performed by representatives for all involved in the design plus specialists with direct responsibility for the design being reviewed D. Formal design reviews a) are a systematic assessment of design results to provide feedback to designers on existing or emerging problems b) are performed by representatives for all involved in the design plus management representatives with direct responsibility for the design being reviewed

Answer 64

A. Formal design reviews a) are a systematic assessment of design results to provide feedback to designers on existing or emerging problems b) are performed by representatives for all involved in the design plus specialists without direct responsibility for the design being reviewed

Question 65

The FDA 21CFR820 Quality System Regulation for Medical Devices defines a process usually referred to as CAPA which is often subject to auditing. Which of the sentences below describe most accurately what CAPA is? A. Customer and patient acceptance B. Quality and production audit C. Corrective and preventive action D. Calculation and prediction assessment

Answer 65

C. Corrective and preventive action

Question 66

A company is considering protecting a medical device invention either by a patent or by a utility model. Which of the statements below describes most accurately these two IP right opportunities? A. A patent requires the invention to be new and industrially useful. A utility model requires the invention to be new, non-obvious and industrially useful. A patent may be valid up to 20 years, whereas a utility model may be valid up to 10 years B. A patent requires the invention to be new, non-obvious and industrially useful. A utility model requires the invention to be new and industrially useful. A patent may be valid up to 20 years, whereas a utility model may be valid up to 10 years C. A patent requires the invention to be new, non-obvious and industrially useful. A utility model requires the invention to be new and industrially useful. A patent may be valid up to 10 years, whereas a utility model may be valid up to 20 years D. A patent requires the invention to be new, non-obvious and industrially useful. A utility model requires the invention to be new and industrially useful. A patent may be valid up to 20 years, whereas a utility model may be valid up to 15 years

Answer 66

D. A patent requires the invention to be new, non-obvious and industrially useful. A utility model requires the invention to be new and industrially useful. A patent may be valid up to 20 years, whereas a utility model may be valid up to 15 years

Question 67

ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Which of the statements below describes most accurately the scope of the standard? A. ISO 14971 is a harmonized standard. The requirements of ISO 14971 are applicable to the design stage of a medical device B. ISO 14971 is a harmonized standard. The requirements of ISO 14971 are applicable to all stages of the life-cycle of a medical device C. ISO 14971 is a harmonized standard. The requirements of ISO 14971 are applicable to the manufacturing stage of a medical device D. ISO 14971 is a harmonized standard. The requirements of ISO 14971 are applicable to clinical testing of a medical device

Answer 67

B. ISO 14971 is a harmonized standard. The requirements of ISO 14971 are applicable to all stages of the life-cycle of a medical device

Question 68

In the Quality System Regulation for medical devices the FDA states that each manufacturer shall maintain device master records (DMR's). The DMR for each type of device shall include, or refer to certain information. Which of the statements below describes most accurately the information required for the DMR? A. a) Device specifications, b) Production process specifications, c) Quality assurance procedures and specifications, and e) Installation, maintenance, and servicing procedures. B. a) Device specifications, b) Production process specifications, c) Quality assurance procedures and specifications, d) Packaging and labeling specifications, and e) Installation, maintenance, and servicing procedures. C. a) Device specifications, b) Production process specifications, c) Quality assurance procedures and specifications, and d) Packaging and labeling specifications. D. a) Device specifications, b) Production process specifications, c) Quality assurance procedures and specifications, d) Packaging and labeling specifications, and e) Design History File

Answer 68

B. a) Device specifications, b) Production process specifications, c) Quality assurance procedures and specifications, d) Packaging and labeling specifications, and e) Installation, maintenance, and servicing procedures.

Question 69

A company is developing a testing kit for diagnosing malaria. The testing procedure is: • Remove the cassette from it’s pouch, and place it on a flat surface. • Cleanse the end of a finger with a sterile swab and dry it with a clean tissue. • With a finger-pricking device carefully prick the end of a finger (at the side) squeezing gently to increase blood flow. • Apply the end of the capillary tube to the blood flow to draw blood into the tube. The blood will automatically flow into the glass capillary tube. Ensure that the glass capillary tube is filled. • By holding the capillary tube in a vertical position immediately apply the blood from the capillary tube into the center of the cassette sample well by pressing the end of the tube onto the absorbent paper in the well. • Allow up to 30 seconds for the specimen to be absorbed before adding the reagent. • Add 5 drops (about 8 µl) of the reagent into the sample well. • Results are read in 5 – 10 minutes for strong positives. • Wait up to 15 minutes for weaker positives and to make sure negatives are confirmed. The company wants to market the testing kit in the European Union. Which of the statements below describes most accurately the relevant regulatory framework? A. The testing kit must meet the requirements of the Active Implantable Medical Device Directive to receive a CE marking B. The testing kit must meet the requirements of the Medical Device Directive to receive a CE marking C. The testing kit must meet the requirements of the In Vitro Diagnostics Medical Device Directive to receive a CE marking D. The testing kit must meet the requirements of the FDA Quality System Regulation for Medical Devices to receive a CE marking

Answer 69

C. The testing kit must meet the requirements of the In Vitro Diagnostics Medical Device Directive to receive a CE marking

Question 70

A company is developing a medical device and wants to perform a clinical investigation in the US. Which of the statements below describes most accurately what is required? A. The clinical investigation requires an Investigational Device Exemption approval from the FDA and an Investigational Review Board must approve the investigation. B. The clinical investigation only requires that an Investigational Review Board approves the investigation. C. The clinical investigation only requires an Investigational Device Exemption from the FDA D. The clinical investigation requires a Pre-Marketing Approval and an Investigational Review Board must approve the investigation

Answer 70

A. The clinical investigation requires an Investigational Device Exemption approval from the FDA and an Investigational Review Board must approve the investigation.

Question 71

The international standard IEC 60529, classifies and rates the degrees of protection provided against the intrusion of solid objects (including body parts like hands and fingers), dust, accidental contact, and water in mechanical casings and with electrical enclosures. Which of the statements below describes most accurately the IEC 60529 standard? A. IEC 60529 is a horizontal standard B. IEC 60529 is a harmonized directive C. IEC 60529 is a vertical standard D. IEC 60529 is a horizontal vertical standard

Answer 71

A. IEC 60529 is a horizontal standard

Question 72

A company is developing a liquid jet injection system with a disposable cartridge. The cartridge material is a polymer and must withstand a pressure of 50 MPa. For reliability and safety reasons it is decided to design the cartridge with a safety margin of 2,0. Which of the statements below describes most accurately the design specification for the pressure robustness of the cartridge? A. 75 MPa B. 100 MPa C. 150 MPa D. 200 MPa

Answer 72

C. 150 MPa

Question 73

The Medical Device Directive lists essential requirements. Which of the statements below describes most accurately the requirement concerned with side-effects? A. Any undesirable side-effect must be eliminated by design B. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended C. Any undesirable side-effect must constitute a negligible risk D. Any undesirable side-effect must be approved by a Competent Authority

Answer 73

B. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended

Question 74

A company is designing a pen-injector for subcutaneous delivery of growth hormone in a liquid solution. The pen-injector employs a spring loaded mechanism to automatically inject the growth hormone solution. ISO11608-3 defines that the force required to overcome friction in the cartridge must not exceed 15 N. The pressure loss in the injection needle is estimated to be less than 5 N, so the total force needed to inject the growth hormone can be expected to be less than 20 N.To ensure proper functionality it is decided to design the spring loaded mechanism with a safety margin of 1,0. Which of the statements below describes most accurately the design specification for the force, Fs which the spring loaded mechanism must be able to provide? A. Fs ≥ 20 N B. Fs ≥ 30 N C. Fs ≥ 40 N D. Fs ≥ 60 N

Answer 74

C. Fs ≥ 40 N

Question 75

A company is designing a prefilled pen-injector for subcutaneous delivery of growth hormone. The pen-injector contains growth hormone for daily delivery up to about one week. When all the growth hormone has been used, the old pen-injector is discarded and a new is taken into use. The company wants to market the pen-injector in the EU. Which of the sentences below describes most accurately the minimum regulatory requirements to the prefilled pen-injector? A. The prefilled pen-injector must comply with the requirements for class IIb medical devices of the EU Medical Device Directive and it must be tested by a Notified Body B. The prefilled pen-injector must comply with the requirements for class IIa medical devices of the EU Medical Device Directive and the requirements of Annex I to the EU Medicinal Product Directive applies as far as quality and safety of the growth hormone are concerned C. The prefilled pen-injector must comply with the with the requirements for class III medical devices of the EU Medical Device Directive, and the requirements of Annex I to the EU Medicinal Product Directive applies as far as quality and safety of the growth hormone are concerned D. The prefilled pen-injector must comply with the EU Medicinal Product Directive, and the relevant essential requirements of Annex I to the EU Medical Device Directive applies as far as the safety and performance-related device features are concerned

Answer 75

D. The prefilled pen-injector must comply with the EU Medicinal Product Directive, and the relevant essential requirements of Annex I to the EU Medical Device Directive applies as far as the safety and performance-related device features are concerned

Question 76

A company is designing a prefilled pen-injector for subcutaneous delivery of growth hormone. The pen-injector contains growth hormone for daily delivery up to about one week. When all the growth hormone has been used, the old pen-injector is discarded and a new is taken into use. The company wants to market the pen-injector in the US. Which of the sentences below describes most accurately the minimum regulatory approval process for the prefilled pen-injector? A. The Company must file a Request For Designation to the Office for Combination Products proposing the primary mode of action to be that of the pen-injector. The approval is handled by the Center for Drug Evaluation and Research. An IND and an NDA is required. B. The Company must file a Request For Designation to the Office for Combination Products proposing the primary mode of action to be that of the growth hormone. The approval is handled by the Center for Drug Evaluation and Research. An IND and an NDA is required. C. The Company must file a Request For Designation to the Office for Combination Products proposing the primary mode of action to be that of the pen-injector. The approval is handled by the Center for Devices and Radiological Health. An IDE and a PMA is required. D. The Company must file a Request For Designation to the Office for Combination Products proposing the primary mode of action to be that of the growth hormone. The approval is handled by the Center for Drug Evaluation and Research. An IDE and a PMA is required. E. Do not know

Answer 76

B. The Company must file a Request For Designation to the Office for Combination Products proposing the primary mode of action to be that of the growth hormone. The approval is handled by the Center for Drug Evaluation and Research. An IND and an NDA is required.

Question 77

A company wants to market a life sustaining medical device in the US. The device is a new version of a device already marketed by the company in the US for the same use. The new device uses the same technology as the previously marketed device. Which of the statements below describes most accurately how the new device is classified and what the appropriate regulatory approval process is? A. The device is class II, 510(k) required B. The device is class II, PMA required C. The device is class III, IDE and PMA required D. The device is class III, 510(k) required

Answer 77

``` C. The device is class III, IDE and PMA required or D. The device is class III, 510(k) required ```

Question 78

A project team wants to estimate the mean time between failures of an otoscope light source. The team decides to apply a testing protocol based on time terminated testing, using 10 testing benches. The testing time is 1000 hours and failed otoscopes are replaced. After 1000 hours of testing on each test bench, only one failure is observed. Which of the statements below describes most correctly the mean time between failures, MTBF? A. MTBF = 1000 hours (= 1000/1) B. MTBF = 10000 hours (= 10000/1) C. 2107 hours (20000/Χ_(0,05;4)^2) < MTBF < 194175 hours (20000/Χ_(0,95;2)^2) with 90% confidence D. 4343 hours (20000/Χ_(0,1;2)^2) < MTBF < 18868 hours (20000/Χ_(0,9;4)^2) with 90% confidence

Answer 78

C. 2107 hours (20000/Χ_(0,05;4)^2) < MTBF < 194175 hours (20000/Χ_(0,95;2)^2) with 90% confidence

Question 79

``` A company wants to perform a clinical investigation in Denmark of a class III CE marked medical device. The purpose of the clinical investigation is to obtain more experience with the performance of the device within its intended use. Which of the statements below describes most accurately what is required? ``` A. The clinical investigation requires authorisation from the Danish Health and Medicines Authority (Sundhedsstyrelsen) and a regional Ethical Committee must approve the investigation. B. The clinical investigation only requires that a regional Ethical Committee approves the investigation. C. The clinical investigation only requires authorisation from the Danish Health and Medicines Authority (Sundhedsstyrelsen) D. The clinical investigation requires a certificate from a Notified Body and a regional Ethical Committee must approve the investigation.

Answer 79

B. The clinical investigation only requires that a regional Ethical Committee approves the investigation.

Question 80

ISO10993 Biological evaluation of medical devices offers the presumption of conformity to the essential requirements of the MDD and AIMDD directives within its scope. Which of the statements below describes most accurately the ISO10993 standard? A. ISO10993 is a harmonized horizontal standard B. ISO10993 is a harmonised directive C. ISO10993 is a harmonized vertical standard D. ISO10993 is a horizontal standard

Answer 80

A. ISO10993 is a harmonized horizontal standard