ISO 14971 Demo free Risk management medical devices Elearning Course

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T 64v19D - Free demo course E-Learning - ISO 14971 Risk management of medical devices version 2019

Presentation T 64

MCT Beginning T 64

1 Risk T 64

2 Definitions, ... T 64

3 Process approach T 64

4 General requirements T 64

Summary of clause 4 T 64

MCT General requirements T 64

5 Risk analysis

Summary of clause 5

MCT Risk analysis

6 Risk evaluation

Case: New risk

Case: Risk register

Case: Risk treatment

Summary of clause 6

7 Risk control

Case: Kaizen and problem

Case: Control measure

Case: Acceptability criteria

Summary of clause 7

MCT Risk evaluation

8 Overall residual risk

Summary of clause 8

9 Risk management review

Case: Design review

Summary of clause 9

MCT Management review

10 Production ...

Case: Nonconformities

Summary of clause 10

MCT Production and ...

MCT End

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MCT Beginning

We will begin with a MCT (multiple-choice test) to evaluate the level of your knowledge

(One or more correct answers are possible, so make sure you tick all the right answers)

1. The requirements of ISO 14971 version 2019 are:

134
309
416

2. During the design of the medical device, the manufacturer:

Identifies hazards
Identifies hazardous situations
Assesses the risks
Implements risk control measures
Collects and analyzes information from production and post-production

3. The characteristics of a MD, relating to safety, concern:

How the MD works
Inteded use
Reasonably foreseeable misuse
Materials in contact with the patient
User error

4. Following the risk evaluation we can:

Analyze the risk
Judge the risk acceptable
Keep control measures as they are
Improve existing control measures

5. The quantitative risk assessment appeared over the years:

1650
1792
2004
2009

Presentation T 64

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