2019年 10月 8日

New European MDCG guidance on MDR Summary of Safety and Clinical Performance (SSCP) rules

New European MDCG guidance addresses SSCP requirements
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2019年 10月 2日

RAPS retrospective: Navigating a challenging medical device regulatory environment

“Navigate your way through the regulatory grey.” That was the tagline for the 2019 Regulatory...
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2019年 9月 27日

TÜV Rheinland becomes fifth Notified Body to obtain designation under the EU MDR

Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical...
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2019年 9月 24日

RAPS recap: Compliance issues for compiling Clinical Evaluation Reports

2019 RAPS Convergence conference examined issues such as CER and clinical data management challenges
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2019年 9月 16日

New details from European Commission on Expert Panels under MDR, IVDR

EC sets parameters of expert panel component of MDR, IVDR
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2019年 9月 11日

European MDR covers cosmetic and aesthetic products: Are these firms ready?

Cosmetic products will need CE Marking to be commercialized in Europe
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2019年 8月 30日

Deal or no deal: Key Brexit-related issues for medical device, IVD sectors

No-deal Brexit now more of a probability
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2019年 6月 26日

South Korean trade group KMDICA teams with Emergo by UL for medical device RA/QA support

The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association,...
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2019年 6月 25日

European Commission forecasts potential supply disruptions due to MDR, IVDR

Commission acknowledges industry concerns about device shortages, Notified Body capacity
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2019年 6月 21日

LRQA réduit ses services d'organisme notifié pour les dispositifs médicaux et les DIV

En raison du Brexit et de questions telles que l'application du RIM et du RDIV, LRQA arrête des activités d'organisme notifié.
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