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Michael Zimmermann
Michael Zimmermann
• Advice on ISO 13485:2003 certification and respective QMS audits.
• Regulatory advice (MDD 93/42/EEC, 90/385/EEC, 98/79/EC).
• Documentation relevant for Conformity Assessment.
• Management of biocompatibility studies according to ISO 10993.
• Design and management of clinical trials (GCP, ICH, ISO 14155).
• Clinical Evaluations according to MEDDEV 2.7.1.
• Negotiations with authorities and Notified Bodies.
• Scientific reports.
• Training and qualification courses and seminars.
02.11.2010

Information

www.proregitas.com
St. Wendel
PROREGITAS Medical Consulting
Worldwide

Qualifications

In total about 25 years international management working experience in the pharmaceutical and medical device industry:
About 11 years industry experience in the management of pre-clinical and clinical research and development projects in various indications.
About 10 years international experience as senior expert and consultant in the areas Medical Device R&D, Regulatory Affairs, Clinical Affairs
Since January 2004 owner and managing director of the PROREGITAS Medical Consulting (service provider with focus on Medical Device Regulatory Affairs, Clinical Research and R&D).
MD Clinical Evaluations, MD Quality Management, MD Regulatory Affairs
Contact
Michael Zimmermann
OFFLINE