Freelancer profile translated to English.
Back to original languageAbout Fabrice Serge
🔬 Biomedical engineer & freelance consultant with 19+ years of experience in Quality, Regulatory Affairs, R&D, and Industrialization for medical devices (class I to III).
🎯 I help MedTech manufacturers, subcontractors, and startups to structure their quality system, prepare their audits (internal & certification), and compile their CE & FDA dossiers.
Also in R&D for product Development phases and documentation structuring.
👉 Available for freelance missions or short/medium-term projects.
French
Native or bilingual
Italian
Native or bilingual
English
Fluent
Can work on-site
Europe Sud (up to 50km), Lyon (up to 50km), Draveil (up to 100km), Toulouse (up to 50km)
Experience
- Qualify / BVI Medical,Process Validation ConsultantMarch 2025 - Today (1 year and 3 months)Liège, Belgium• - Writing IQ/OQ/PQ validation protocols• - FDA 21 CFR part 820 and ISO 13485 compliance❖ Support for FDA pre-approval inspection (May 2025) – successful inspection❖ Support for QMS compliance / Training and internal audits conducted
- Groupe AFNOR(Freelance mission)May 2024 - Today (2 years and 1 month)- Internal audits and ISO 13485 third-party audits- CE and FDA (510k) technical file evaluation- Participation in MDSAP certification audits
- Medline SASQARA ManagerJanuary 2023 - January 2024 (1 year)• - Internal audits and ISO 13485 third-party audits• - CE and FDA (510k) technical file evaluation• - Participation in MDSAP certification audits•
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Education
- Specialized Master, Hospital and Technical Services ManagementUniversité de Technologie de Compiègne2012Mastère Spécialisé , Management Hospitalier et des Services Techniques
- Biomedical Engineer, Medical DevicesPolitecnico di Milano2009Ingénieur Biomédical, Dispositifs Médicaux