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Revision as of 13:07, 28 March 2020
Michael Maier is member of the 2018 Guideline Development Group (GDG) of the WHO. The GDG's task is to develop updated recommendations on safe male circumcision for HIV prevention and related service delivery for adolescent boys and men in generalized HIV epidemics.[1]
Biography
The WHO published the following biography of Michael Maier:
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 pro-grams. 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
- > 50 reviews of technical files and design dossiers for Notified Bodies
- > 100 trainings / lectures given on Medical Device RA / QA
- Troubleshooting missions
- FDA Mock inspections
- > 6 years responsible for design & development in the fields of anesthesia and ventilation, cardiology, laparoscopy
Michael is fluent in German, French and English.[2]
References
- ↑
(May 2018). WHO to develop new guidelines on male circumcision
. Retrieved 26 March 2020. - ↑
Biographies of Guideline Development Group (GDG) members for WHO guidance 
, WHO. (September 2018). Retrieved 26 March 2020.
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