1.
Organization designated to assess conformity under the MDR
2.
International standard for medical device quality management systems
3.
European Medical Device Regulation acronym
4.
Documentation that demonstrates a device is fit for use and meets requirements
5.
U.S. regulatory agency overseeing medical devices
6.
Abbreviation for the Quality Management System
7.
Failure analysis tool used to identify and prioritize risks
8.
Corrective and Preventive Action acronym
9.
Activities performed to ensure products consistently meet requirements
10.
Requirement to maintain records demonstrating compliance throughout the product lifecycle
11.
Product issue or customer concern that may require investigation
12.
European conformity designation required for marketing many medical devices
13.
Process of confirming outputs meet design inputs
14.
Record documenting investigation, root cause, and corrective actions
15.
Formal process used to identify, assess, and control product risks
16.
to evaluate a design and identify any potential issues or improvements
17.
What group continuously monitors safety, performance, and effectiveness of a product after it has entered the general market
