MCT Beginning

1. The characteristics of a MD, relating to safety, concern:

• How the MD works
• Inteded use
• Reasonably foreseeable misuse
• Materials in contact with the patient
• User error

2. The quantitative risk assessment appeared over the years:

• 1650
• 1792
• 2004
• 2009

3. 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

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 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