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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12 January 2020
MDCG 2019-15 Guidance Notes Class I Medical Devices
MDCG 2019-15 Guidance Notes For Manufacturers of Class I Medical Devices
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14 December 2019
DEKRA Certification B.V. designated under MDR
DEKRA Certification B.V. is the 3rd dutch notified body designated under EU MDR
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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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