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Medical Device Manufacturing Practice > Online Test 1 > Flashcards

Online Test 1 Flashcards

1
Q

Why control or regulate medical devices

A

To protect public health and safety by

  • Putting devices on the market safely
  • Having a mechanism to remove unsafe products
  • Offering product information to consumers to allow informed choice making
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2
Q

What can go wrong with unregulated medical devices

A
  • Counterfeits

- Misrepresentation/ Overstating of performance

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3
Q

Medical device life cycle

A

Three stages of Medical Device lifecycle:

Pre-market, Placing on market, Post-market

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4
Q

List the regulatory organizations for medical devices

A

WHO, GHTF > IMDRF, APEC, AHC, AWHP & Pan American Health Org

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5
Q

Describe a regulatory framework

A

A regulatory framework lists the legislation, risk classification system and regulatory body the different countries abide by.

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6
Q

What is risk classification for medical devices

A

In ASEAN/GHFT, Class A-D

In EU, Class I to III

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7
Q

Why the need to classify by risk?

A
  • To ensure patient safety
  • For the manufacturing process to minimize adversities
  • For regulatory bodies to understand how stringent they should be on different risk devices
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8
Q

How to do risk classification?

A 
Refer to: 
Intended Use 
Indication
Duration of Contact
Degree of Invasiveness
Delivery
Biological Effect
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9
Q

Risk Classification Rules (Flowchart Sections)

A

Non-Invasive
Invasive
Active
Additional Rules

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10
Q

What are General requirements for Essential Principles for Safety, Performance and Quality compliance for use of medical devices?

A
  1. Design and manufacture must not compromise consumer health and welfare
  2. Problems for risks and problems should conform to safety principles
    a) foresee & identify
    b) reduce & mitigate
    c) add measures for unavoidable risks
    d) inform users of residual risks
  3. design, manufacture and packaging must preserve performance
  4. Performance of medical device under stress must not harm consumers when properly maintained
  5. transport and storage must not affect performance
  6. Benefits must outweigh risks
  7. Clinical evidence detailing appropriate use, risk classification, and conformity to relevant essential principles mandatory
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11
Q

What are the standards used for medical devices?

A

Basic (Horizontal), Group (Semi-Horizontal) and Product (Vertical)

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12
Q

What does standards used for medical devices show?

A

Shows the type of medical device and the requirements of that device based off risk

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13
Q

What is Conformity Assessment?

A

Systematic examination of evidence by manufacturer, as required of regulatory body to ensure safety of device, and compliance to essential principles of safety, performance and quality performed pre and post-market, as well as provides evidence of safety, risk, and performance

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14
Q

Elements of Conformity Assessment

A 
Post-Market Surveillance System
Quality Management System
Registration of persons
Registration of device
Declaration of conformity
Technical Documentation
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15
Q

What is Conformity Assessment Procedures?

A

Process used by manufacturers to demonstrate compliance to essential principals

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16
Q

What is QMS on the factory floor?

A

QMS is a management system that directs and controls an organization’s product quality, including the organizational structure, responsibility procedures, processes and resources for implementing quality management.

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17
Q

QMS areas (company/org)

A 
Design
Manufacturing
supplier management
risk management
complaint handling
clinical data
storage
distribution
product labelling
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18
Q

How to comply to a QMS as required by regulatory controls

A

Manufacturers must ensure the designed, manufactured and supplied MD are safe, perform as intended, and complies to regulations

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19
Q

What are QSR and ISO13485 standards for medical device manufacturing?

A

They are to ensure manufacturers consistently design, produce and place on the market medical devices that are safe, and fits the intended use.

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20
Q

Requirements for ISO13485 standard for medical device manufacturing

A

ISO13485 requires a QMS that can be demonstrated to consistently meet customer requirements and regulatory requirements

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21
Q

What is Good Distribution Practices (GDP)?

A

guidelines used for distribution and quality control to maintain quality & integrity of medical devices throughout supply chain
-ISO 13485 > GDP

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22
Q

requirements of GDMPDS

A
  1. Quality Management System
  2. Resource Management
  3. Buildings and Facilities
  4. Storage and Inventory Handling
  5. Products Traceability
  6. Handling of Complaints
  7. Field Safety Corrective Action (FSCA)
  8. Return of Medical Devices
  9. Destruction/disposal of Medical Devices
  10. Illegal and Non-conforming Medical Devices
  11. Internal Audit
  12. Management Review
  13. Third-Party Activity or Outsourcing Activity
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23
Q

What is Quality Agreement?

A

A written agreement establishing the responsibility and obligation between the distributor and third-party service provider

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24
Q

What are the steps in a medical device design and development?

A
  1. Design and development plan
  2. Design product
  3. Design for manufacturing
  4. Design verification
  5. Design validation
  6. Design reviews
  7. Design change assessment
  8. And Design history file
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25
What are the requirements in ISO13485 for manufacturing?
Organization must demonstrate the ability to consistently comply to customer and regulatory requirements
26
Product Design Step 1
Design & Development planning: Documentation of: a) the design and development stages; b) the review(s) needed at each design and development stage; c) the verification, validation, and design transfer activities that are appropriate at each design and development stage; d) the responsibilities and authorities for design and development; e) the methods to ensure traceability of design and development outputs to design and development inputs; f) the resources needed, including necessary competence of personnel
27
Product Design Step 2
Design input: * To have a design so that the device’s purpose and the intended use are clear * Use performance, safety, business economics * Risk management includes risk management plan, results of risk assessment and risk control. It is commonly conducted according to ISO 14971 * Applicable regulatory requirements and standards
28
Product Design Step 3
Design Output: * Output and Test procedures * Meet the input requirements or show conformance for design and development * Design output must be in a form suitable to be verified against the design input
29
Product Design Step 4
Design Review: documented, systematic, comprehensive examination of design to: -review design at appropriate stage -evaluate capability of meeting requirements -identifying problems
30
Product Design Step 5
Design Verification (DVE): Verify using objective evidence that a) output meets input Establish and maintain procedures for verification: a) review, approve and document in DHF b) confirm through measurable means
31
Product Design Step 6
Design Validation: Establishes using objective evidence that a) user needs and intended use are met Manufacturers must establish and maintain procedures: a) under defined operating conditions b) On initial production units, lots or batches c) Under actual or simulated use conditions
32
Product Design Step 7
Control of Design Changes: Manufacturers must establish and maintain procedures for identification, documentation, validation for review and approval of design changes before implementation
33
Product Design Step 8
Design Transfer: - Documentation of procedures for the transfer of D&D output - procedures must ensure outputs are verified for manufacturing - production capability meets production requirement - concluding results recorded
34
Product Design Step 9
Design History File (DHF): Files evidence (i.e. the history of the design) that shows : That design was developed in according to othe design controls othe design and development plan, oor the design-change plan
35
Tools regulatory bodies use
``` Regulatory control Risk classification Essential principles Standards Template for registration requirements Registration Monitoring ```
36
Medical Device Life Stages
Premarket, Placing on market, Postmarket
37
Premarket
Design and development, Manufacturing, Packaging and Labelling
38
Placing on Market
Sales, Advertising
39
Post-Market
Use, Surveillance, Vigilance, Disposal
40
Duration of Contact
``` Transient (<60 minutes) Short term (up to 30 days) Long term (>30 days) ```
41
Degree of Invasiveness
- Non-invasive - Invasive through a body orifice - Surgically Invasive - Implantable
42
Delivery
- Energy | - Medicinal Products
43
Biological Effect
- Local | - Systemic
44
Two categories of essential principles
General requirements | Design and manufacturing requirements
45
ISO 13485
requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device
46
What is Design Control
Beginning at pre-market, set of interrelated practices and procedures that are documented and incorporated into the design and development process, using simple and logical steps to ensure that medical devices meet user needs, intended use needs and all specified requirements, thus ensuring the medical device is safe and effective.
47
3 important stages of product development
conceptualize, design, implement
48
Purpose of controlling design process
to fulfil the obligations to the regulatory authorities and help companies save time and money by ensuring the design outputs are relevant
49
Design and Development planning stage includes
• Design and development activities • Allocate responsibilities and authorities for each activity • Review, update and approve the plan • It is an ongoing process Until the device design is completed, verified and validated
50
Design input stage includes
* To have a design so that the device’s purpose and the intended use are clear * Use performance, safety, business economics * Risk management includes risk management plan, results of risk assessment and risk control. It is commonly conducted according to ISO 14971 * Applicable regulatory requirements and standards
51
Design output stage includes
* Output and Test procedures * Meet the input requirements or show conformance for design and development * Design output must be in a form suitable to be verified against the design input
52
Medical Device file content
a) general description of the Medical Device, intended use or purpose, labelling, including any instructions for use; b) specifications for product; c) specifications or procedures for manufacturing, packaging, storage, handling and distribution; d) procedures for measuring and monitoring; e) as appropriate, requirements for installation; f) as appropriate, procedures for servicing
53
ISO 13485 Documentation
Design & Development, Purchasing Process, Cleanliness of product, Installation activities, Servicing activities, Identification
54
D&D Documentation
Document procedures for D&D, including verification & validation, ensure that designs & outputs are fit for manufacturing
55
Purchasing Process
1. Document Purchasing Procedure 2. Document criteria for evaluation & selection of suppliers: a) supplier’s ability to provide correct product b) performance of the supplier c) effect of the purchased product on the quality of the MD d) The effect is proportionate to the risk of the MD
56
Product Cleanliness Documentation
Document cleanliness or contamination control of product
57
Installation Activities Documentation
Document requirements for installation & acceptance criteria for verification of installation Include activities done by 3rd parties records must be maintained
58
Servicing Activity Documentation
``` documents of: servicing procedures reference materials reference measurements are required for servicing and verification of product requirements met ```
59
Identification Documentation
- Maintain documentation of product identification throughout premarket until dispatched, used or installed - returned products are distinguished from conforming products - Maintain document throughout lifecycle
60
9 Parts of Design Control
1. Design and Development Planning 2. Design Input 3. Design Output 4. Design Review 5. Design Verification 6. Design Validation 7. Control of Design Changes 8. Design transfer 9. Design History File
61
7 QMS areas
``` Process and production control chain management corrective and preventative action (CAPA) Management Responsibility Resources Product surveillance design control ```
62
Design Input (Stage 2)
Address 1. Dimensions, characterizations – physical requirements of device, material strength, material flexibility. For example for stent and balloon angioplasty, what should be the stent deployment pressure and the ability of the balloon catheter to be withdrawn from the stent 2. Device performance requirements 3. Safety like Biocompatibility – for implants, there must be minimum immune reaction from the body, integrates into surrounding native tissue 4. Packaging to improve ease of use 5. Storage needs 6. Shelf life 7. Regulatory/standards compliance – which standards to reference for the requirements
63
Design History File of D&D
* Records of the results of the reviews * Any necessary actions shall be maintained * Identification of the design under review * Participants involved * Date of the review
64
Purpose of QMS
ensures that MD are safe and effective, satisfy customer quality requirements and expectations, ensure labelling and product information is complete and correct, and comply with regulatory requirements.
65
Benefits of QMS
less wastage efficient and effective process consistent quality prompt detection of defects
66
Purpose of Design Control
Save time and money Fulfil regulatory requirements Meet the customer need, expectation Safe and performs as intended
67
Purpose of Design Control
Save time and money Fulfil regulatory requirements Meet the customer need, expectation Safe and performs as intended
68
Post Market records
- Product identification and traceability - Handling of returns - Preservation of product - Feedback process - Complaint handling - Reporting to regulatory authorities - Control of non conforming product - Rework - Analysis of data - Corrective action and Preventive actions

Medical Device Manufacturing Practice (4 decks)

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