MCT Beginning

1. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416

2. 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

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. 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

5. 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