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 10+ years as a notified body contract Lead Auditor for DEKRA.
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News
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1 November 2021MDCG 2021-26 Q&A on repackaging & relabelling activities
MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
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7 October 2021New MDCG guidance document MDCG 2021-24
New MDCG guidance MDCG 2021-24 for the classification of medical devices has been published.
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6 September 2021TUV Rheinland Italia designated Notified Body MDR
TUV Rheinland Italia designated Notified Body MDR.
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