MCT General requirements

1. The cost of risk management during production is:

• Between 10 to 100 times higher than during design
• Between 1,000 to 10,000 times higher than during design
• Between 100 to 100,000 times higher than during development

2. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416

3. 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

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

• Effect of uncertainty on the achievement of objectives
• Combination of the probability of an event and its consequence
• Combination of the probability of occurrence of harm and the severity of that harm
• Effect of uncertainty

5. Top management's commitment is to:

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