MCT General requirements

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

• Risk analysis
• Competence of personnel
• Risk evaluation
• The results of the residual risk evaluation

2. Top management's commitment is to:

• Establish the risk policy
• Manage good practices
• Assign responsibilities and authorities
• Allocate the necessary resources

3. Risk:

• Is inevitable
• Is intrinsic to any activity
• Can be eliminated
• Cannot be eliminated
• Can be reduced

4. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416

5. The process mapping allows us to:

• Identify the beneficiary
• Plan the MS (management system)
• Identify the interactions
• Manage inspection means
• Obtain a global vision