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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...
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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...
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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...

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A single review program for medical devices?

Dec 2, 2019

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The question on clients’ lips… “How long will my application take?”

Nov 4, 2019

TGA Publishes updated MDIR Guide

Oct 31, 2019

EU Software Classification under MDR/IVDR – New Guidance Document

Oct 28, 2019

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