Flexa-MD
Medical-device design, regulatory and quality consulting for MedTech companies
Highlights
- Young companyFounded 2023
- New on EvolcAdded 2026-11-09
About Flexa-MD
FleXa-MD advises medical-device manufacturers from user-needs definition through product design, regulatory submissions and post-market follow-up. Its work covers SaMD, surgical instruments and implants, including devices that incorporate AI.
It provides consulting and training to startups, small and medium-sized businesses, and larger MedTech groups. Services include design controls, risk management, EU MDR and US FDA regulatory strategy, ISO 13485 quality systems, and audit preparation.
FleXa-MD is based in Besançon, France. The company was founded in 2023 and is led by a senior consultant with experience in medical-device R&D, project management and regulatory compliance.
Product: Consulting and training in medical-device design, regulatory compliance and quality systems, including support for AI-enabled devices.
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