Jamila Ahdidan

Are you developing or marketing a medical device and navigating the regulatory complexity of EU MDR/IVDR, FDA, or ISO 13485? I help you turn these requirements into a competitive advantage — without slowing down your time-to-market.

With 17 years of experience in MedTech, including a decade as co-founder and CTO of a SaMD startup (AI neuroimaging software with CE marking and FDA 510(k) clearance), I know your challenges from the inside: building a robust QMS, writing compelling technical documentation, leading a product team under regulatory constraints — and doing it with limited resources.

What I offer you concretely:

An expert review of your regulatory situation (EU MDR, IVDR, FDA 21 CFR 820, IEC 62304, ISO 14971) to identify risks and priorities

The writing and updating of your key deliverables: CER/CEP, Risk Management File, Technical Documentation, PSUR, SOPs, and QMS procedures

Strategic support in regulatory and product project management, from design to market launch

My difference: I've lived the full cycle — from research to CE marking and FDA clearance — as a leader, not just a consultant. I speak the language of technical teams, quality teams, and investors. Trilingual in French / English / Danish, I work on both European and international projects.

Typical projects: regulatory audits, gap analysis, CER/CEP writing under MDR, 510(k) submissions, ISO 13485 QMS implementation or remediation, IVD/SaMD risk management, advice on classification and regulatory strategy.