Tag Archives: Medical Device Regulation
The new 2017/745/EU Medical Device Regulations (MDR-2020) require increased emphasis on Post- Market Clinical Follow-Up (PMCF) as a part of clinical evaluation to demonstrate conformity to safety and performance of devices. Many device manufacturers are unaccustomed to conducting post- marketing … Continue reading
Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps … Continue reading
Webinar on Unique Device Identification (UDI): What and How within overall Medical Device Value Chain.
Free Webinar on Unique Device Identification (UDI) – June 18th 2015. Planning and Implementation of the Medical Device Regulation (UDI) Step 1. Developing the UDI compliance plan Brief senior management on project scope and provide resource requirements with cost Receive … Continue reading