QA/RA Product & Project Manager Expert in Medical Device

My name is Dieudonné M.. I have been a professional in the Medical Device Field for 20 years and am currently working as a consultant in the areas of R&D, Manufacturing, Quality, and Regulatory Affairs in Europe, North America, and Asia.

• Artificial intelligence
• Audition6 J.
• Medizintechnik4 J.
• Notify Body Auditor
• Projektmanagement
• Qualitätsmanagement / QS / QA (IT)5 J.
• Technisches Projektmanagement9 J.
• Technisches Qualitätsmanagement / QS / QA

My name is Dieudonné M.. I have been a professional in the Medical Device Field for 20 years and am currently working as a consultant in the field in areas of R&D, Manufacturing, Quality, and Regulatory Affairs in Europe, North America, and Asia.
My Projects involved working on products of classes I-II-III, Combination devices (drug-device), and in Vitro Diagnosis (IVDD/ IVDR). I am also providing support to several Notified Bodies in Europe, like DQS, TUV Nord, and SGS, as Lead Auditor and Technical Documentation reviewer for MDR, MDD, MDSAP, ISO 13485, and ISO 9001.
After graduating from the University of Karlsruhe (Germany) in February 2007 as a Mechanical Engineer specializing in Medical Technology and Mechatronics, I completed further studies in Executive Management at the University of Plymouth (Executive Management) and Business Management at both the University of Georg-Simon-Ohm University in Nurnberg and Zhejiang University in Shanghai (China).

found in profile qualification
Expertise in Business Management, Product Management, Production Management, Supply Chain Management.
- Proficient in ISO-13485 and ISO-9001, ISO 19011, DIN EN ISO 14971, 21CFR Part 820, 21CFR Part 11,
GAMP5, IEC 62304, IEC 82304, IEC 60601, IEC 62366; MDR 2017, UL 2900-1 & UL 2900-2-1; TIR57_AAMI; IEC
80601; ISO 10993-1; ISO 17664…
- Proficient in:
o MDD 1993
o MDR 2017 (Medical Device Regulations)
o IVDD
o IVDR 2017
o Clinical Evaluation
o Biocompatibility (Biological Safety Evaluation)
o Technical documentation
o CE-Conformity Assessment
o FDA 510 (K) Submission preparation
o Product Development
o Usability Engineering
o Risk Management
o FMEA (DFMEA, PFMEA, Use FMEA)
o Product Security Management (Cybersecurity)
o Quality Assurance
o Quality Management Requirements (Writing QMS Procedures)
o Quality control
o Project Management
o Process optimization
o Change control
o Auditing
o Qualification/ Process validation
o CAPA System (CAPA Investigation, Resolution, Mitigation measures)
o Clean Room Requirements
o Packaging