International Devices & Diagnostics Monitor
December 11, 2015
One of the impacts of the changes in the MDR will be more clinical data and an end to market entry based on equivalence for high-risk devices and lower risk implants.
Gert's advice 'stay calm and make the transition'.
IDDM Interview: FDA_IDDM Article Gert Bos.pdf
Qserve Whitepaper: Compliance Alert: MDR & Notified Body Update