EU adopts rules for auditing medical devices, IVDs

09/24/2013 | Clinica

The European Commission has adopted two rules on the role of notified bodies in reviewing medical devices and IVDs. "We now have a clearer basis for unannounced audits, sample testing or joint assessments by notified bodies," said EU Commissioner for Consumer Policy Neven Mimica. Authorities consider these interim rules vital to providing additional patient safeguards for medical devices since full regulatory implementation may be years away.

View Full Article in:

Clinica

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Product Development Manager, Disposable Medical Products
ASAHI INTECC, Orange County CA R&D Center
Santa Ana, CA
Neurovascular Intervention Product Sales Rep, North East
ASAHI INTECC
Multiple Locations, SL_Multiple Locations
Vice President of Regulatory Affairs
Pentec Health
Boothwyn, PA
Sr Coordinator Clinical Research (US/TA/00/0073/SL) - 1400000AQX
Abbott
Santa Clara, CA
Senior Director, Biostatistics
Edwards Lifesciences
Irvine, CA