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ISO 14971 Demo free Risk management medical devices Elearning Course

MCT General requirements

Let's continue with this MCT (multiple-choice test) to see what you have learned about general requirements 
(One or more correct answers are possible)

                        

1. Risk:

                        

2. According to ISO 14971 version 2019 the risk is:

                        

3. The risk management file makes it possible to maintain traceability in relation to:

                        

4. The risk management plan includes:

                        

5. The requirements of ISO 14971 version 2019 are: