Tackling Clinical Evaluation Head On
TBMG-33574
01/01/2019
- Content
When a medical device is placed on the market, it is critical for the manufacturer to demonstrate through appropriate Conformity Assessments (CAs) that the device complies with the Essential Requirements (ERs) as set out in the Medical Devices Directives (MDD). The manufacturer needs to demonstrate that the device achieves its intended purpose, that any known (or possibly foreseeable) risks are minimized and weighed against the benefits of the intended use, and that any claims about the device's performance are supported by evidence.
- Citation
- "Tackling Clinical Evaluation Head On," Mobility Engineering, January 1, 2019.