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 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

3. 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

4. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416

5. 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