Meinrad Guggenbichler
Head of the Notified Body (Medical Devices) @Mdc Medical Device Certification Gmbh
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WORK HISTORY
Head of the Notified Body (Medical Devices) @Mdc Medical Device Certification Gmbh
Stuttgart, DE
mdc is a notified body for medical devices under Regulation (EU) 2017/745 (MDR) and Directive 93/42/EEC (MDD) as well as for in-vitro diagnostics under Directive 98/78/EC (IVDD) and Regulation (EU) 2017/746 (IVDR - pending).
EDUCATION
Technical University of Munich
Diplom / MSC, Maschinenbau
FAU Erlangen-Nürnberg
Vordiplom, Maschinenbau
Höhere technische Bundeslehranstalt
Matura/Abitur, Bauwesen / Hochbau
SKILLS
ABOUT MEINRAD GUGGENBICHLER
After starting as a lead auditor under Directive 93/42/EEC (MDD), 98/79/EC (IVDD) and Regulation (EU) 2017/745 (MDR) as well as quality auditor for EN ISO 9001:2015 and EN ISO 13485:2016 and the MDSAP program and expert for technical review of medical devices I was appointed head of the notified body for medical devices of mdc mid 2020, shortly after out notification against MDR.Together with the team at mdc I am responsible for thetimely and correct performance of the certification projects and the conformity of the implemented quality management system.I also love to pass on knowledge during workshops on medical devices including risk management, technicaldocumentation, vigilance and PMS.
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