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 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. 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

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 quantitative risk assessment appeared over the years:

• 1650
• 1792
• 2004
• 2009