Online Test 1 (1a - 2c)

Question 1

Definition of medical devices

Answer 1

Instrument, machine, software etc, intended by product owner to be used either alone or in combination for human beings for purpose(s) such as:
Diagnosis, prevention, monitoring etc
And does not achieve this via immuno, pharmo, or metabolic means

Question 2

In vitro

Answer 2

Outside of living organism

Question 3

IVD

Answer 3

Specimens taken from patient and never reintroduced to patient again

Question 4

In Vivo

Answer 4

Within the human body

Question 5

Distinguish between medical device and drug

Answer 5

• primary mode of action is not immuno, pharmo or metabolic
• diagnostic and therapeutic
• physical object/ software
• can be ex vivo
• physical interaction with body (part)
• training needed
• effectiveness dependent on skill
• designed and invented
• batch size differ

Question 6

Why control or regulate medical devices

Answer 6

Protect public health and safety

• put product safely on the market
• have mechanism to remove unsafe products from market
• product info for public and operators to make informed choices on safe use of medical devices

Question 7

What can go wrong with medical devices

Answer 7

Counterfeits and misrepresented performance

-affect patient health

Question 8

Medical device lifecycle

Answer 8

Premarket
Placing on market
Post market

Question 9

Premarket

Answer 9

Conception and development
Manufacture
Packaging and labelling

Question 10

Placing on market

Answer 10

Advertising

Sale

Question 11

Post market

Answer 11

Use

Disposal

Question 12

Key Organizations

Answer 12

World Health Organization (WHO)
Global Harmonisation Task Force (GHTF)/ International Medical Device Regulators Forum  (IMDRF)
Asia-Pacific Economic Cooperation (APEC)
APEC Harmonisation Centre (AHC)
ASEAN
American Health Organisation 
Asian Harmonisation Working Party (AHWP)

Question 13

International Medical Device Regulators Forum

Answer 13

Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea, USA

Question 14

Global Harmonisation Task Force

Answer 14

Canada, USA, European Union, Japan, Australia

Replaced by IMDRF in Oct 2011

Question 15

USA and global standard

Answer 15

21 CFR Part 820, ISO 13485

Question 16

US, EU, Australia, Canada, Singapore and Malaysia Regulation years

Answer 16

1976, 1993, 1989, 1975, 2010 (Singapore Health Product Act by HSA), 2012

Question 17

Describe a regulatory framework

Answer 17

Contains legislation, regulatory bodies and risk classification system abided by each country

Question 18

What is risk classification for medical devices

Answer 18

IMDRF/ASEAN: Class A-D

EU: Class I-III

Question 19

Why the need to classify by risk?

Answer 19

1. Patient safety and assurance
2. Product Owner development process
3. Regulatory body risk classification

Question 20

What is conformity assessment

Question 21

Elements of conformity assessment

Question 22

Procedure of conformity assessment

Question 23

What are standards used for medical devices

Question 24

What does the standards for medical devices show?

Question 25

What are essential principles for safety, performance and quality compliance for use of medical devices?

Question 26

What is the scope of the standard systems for the manufacturing of medical devices?

Question 27

How to comply to a QMS as required by regulatory controls

Question 28

What is QSR and ISO13485 for manufacturing

Question 29

What is a QMS on factory floor?

Answer 29

QMS is the responsibility of top management, and demands good communication at all levels from customers to management

Question 30

Risk Classification rules (flowchart)

Question 31

What are the 7 areas QMS covers

Answer 31

Design control, process and production control, change management, corrective and preventative action, management responsibility, resources, product surveillance

Question 32

QMS is a structured system of

Answer 32

Policies Procedures Processes

Question 33

Purpose of QMS

Answer 33

-ensure quality control -ensure device safety and effectiveness -satisfy customer quality expectations -ensure labelling and information is correct and complete -comply to regulatory requirements and help companies achieve it's -mission, visions, goals, quality

Question 34

Good QMS Control procedure results

Answer 34

- Less wastage - Efficient and effective process - prompt detection and defect correction - consistent quality

Question 35

Definition of Medical Device QMS

Answer 35

systematic examination of evidence showing