MCT Beginning

1. The purpose of reviewing the information collected is to determine whether:

• New hazards have occurred
• New hazardous situations have occurred
• The state of the art has evolved
• The risk of a hazardous situation has become unacceptable
• The overall residual risk has become unacceptable
• The overall residual risk has become unacceptable

2. To evaluate the risks related to the saety of the medical device after the start of marketing:

• A risk management plan is used
• A production information collection system is used
• A system for collecting post-production information is used
• A production information review system is used
• A post-production information review system is used
• A post-market monitoring plan is used

3. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416

4. 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

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