MCT Beginning

1. 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

2. During the design of the medical device, the manufacturer:

• Identifies hazards
• Identifies hazardous situations
• Assesses the risks
• Implements risk control measures
• Collects and analyzes information from production and post-production

3. The risk analysis takes into account:

• The impact of risk
• The likelihood of the risk occurring
• Risk control measures
• The root causes of risk
• Interaction with other risks

4. 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

5. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416