×

Reform

f9a57bfe-51c7-11e9-8939-5623721d3707

Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…

By Arthur Brandwood | 03.30.2019
Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...
shutterstock_708015040

NZ Makes it Formal – Medical Devices Reform in The Land of the Long White Cloud

By Arthur Brandwood | 03.28.2019
New Zealand has always been a relaxed sort of place – and that included the regulation of medical devices which up till now has been limited to a simple notification...
Sauce

China update – regulation with a European sauce?

By Arthur Brandwood | 08.07.2018
CFDA continues to propose more changes to medical device regulation, and as ever the agency looks to international practices and seeks to weave them in to China requirements. A recent...

Search

Recent Posts

Australian TGA To Introduce AusUDI

Aug 19, 2019

Cybersecurity – Is Your Device Software Secure?

Aug 13, 2019

Inaugural Course on Molecular Toxicology

Aug 5, 2019

Beyond a business merger, diverse skills come together at Brandwood CKC

Aug 5, 2019

Applications Closing Soon – November PL.

Aug 1, 2019

Importance of Innovation

Jul 29, 2019

Categories

Categories

Archives

Archives

Archives

Tags

3D 3D printing 510(k) 510(k) PMA adverse events Apple Watch Artificial Intelligence Australia Biocompatibility Biomechanics Brexit CE CE Certificates CFDA China clinical evidence distribution Europe FDA Health Canada IVD IVDR MDR MDSAP mechanical properties medical device medical devices New Zealand Notified Bodies PMA PMDA post market postmarket premarket Quality Systems Reform regulatory Reimbursement SaMD Software standards Sterilisation TGA UDI Webinar
Translate »