Expert in medical device standards and CE regulations
This expertise is gained in over 25 years working in various roles in the medical device industry, including 9+ years as a notified body contract Lead Auditor for DEKRA.
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News
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13 November 2019
MDCG 2019-11 Software classification in the MDR and IVDR
Last month the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation MDR and IVDR.
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27 September 2019
TÜV Rheinland 5th Notified Body MDR
TÜV Rheinland 5th Notified Body under EU-MDR.
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19 September 2019
US asked to push back the deadline for the new EU MDR requirements.
The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years.
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