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<blockquote>'''Maier, Michael'''
* Medidee Services SA
* {{MBA}}, Dipl.Ing. Medical Engineering.
* Chables, Switzerland
Michael has 20+ years of hand on experience within medical device industry in design & development projects, product industrialization and regulatory & quality affairs. Michael is a trained Notified Body auditor for ISO 13485 and MDD and has served numerous international compliance programs. Michael helps clients determining the most appropriate regulatory pathways and strategies to bring medical devices to markets. Michael supports you with regulatory troubleshooting and compliance audits for product files, clinical investigation files and quality systems.
Michael holds an {{MBA }} in corporate management, a master in Medical Engineering and a Swiss Certificate of Capacity as precision mechanic. Michael is member of the ISO TC 210 WG on Post Market Surveillance. Regularly, he is speaker in international events for medical devices, quality and regulatory affairs topics.
* > 600 audit days of MD manufacturers under ISO 13485, CMDCAS, MDD