MCT QMS T 22

1. The medical device file contains:

• Process mapping
• Product description
• Nomenclature
• Measurement and monitoring processes

2. The level of risk of the processes is identified in relation to:

• Effectiveness of the QMS
• Impact on the safety of medical devices
• Impact on the performance of medical devices
• Impact on regulatory conformity

3. The general requirements request that the QMS be:

• Documented and implemented
• Established, documented, implemented and maintained
• Established, documented and implemented

4. The procedure control of records ensures for records:

• Updating
• Identification
• Retention time
• Verification
• Disposal

5. The quality manual:

• Is a document setting out the general provisions of a business to obtain conforming products or services
• Is a set of actions to carry out a process
• Includes all procedures
• Is a mandatory element of an ISO 13485 certified QMS