Senior Partner, medidee
Michael Maier has 25 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 is fluent in German, French and English.
Michael holds an MBA in corporate management, a Dipl.Ing. in Medical Engineering and a Swiss Certificate of Capacity as precision mechanic. He earned his RAC Devices in 2019.
Michael is member of several standardization committees related to Medical Devices, serves in the REC for RAPS and as Vice President Medical Devices for RAPS Switzerland Chapter. Regularly, he is speaker in international events for medical devices, quality and regulatory affairs topics.