ISO 14971 Demo free Risk management medical devices Elearning Course

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T 54v19D - Free demo course E-Learning - ISO 14971 Risk management of medical devices version 2019

Presentation T 54

MCT Beginning T 54

1 Risk T 54

2 Definitions, ... T 54

3 Process approach T 54

4 General requirements T 54

Summary of clause 4 T 54

MCT General requirements T 54

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 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

2. Risk reduction is confirmed by:

Checking the implementation of the control measure
Verifying the effectiveness of the control measure
Carrying out tests with users
Recording the results of veryfying the effectiveness of control measures

3. The requirements of ISO 14971 version 2019 are:

134
309
416

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 evaluation of the overall residual risk takes into account, among other things:

The sum of individual risks
The sequence of events
Special harm
Risk control measures in conflict with other requirements
Too many warnings

Presentation T 54

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