Over Mehdi
Medical doctor and biostatistician (MD, MSc) with 10+ years supporting clinical development, regulatory submissions, and scientific content creation for pharmaceutical, MedTech, and IVD companies.
What sets me apart: I don't just write documentation, I help define the clinical strategy behind it. Endpoint selection, success criteria, benchmarking against state of the art. My dual MD + biostatistics background lets me solve these upstream questions, then carry through to the final deliverable. One consultant instead of three.
What I deliver:
→ Clinical study design : endpoint definition, protocols (CIP), SAPs, sample size calculations, benchmarking against predicates
→ Regulatory documentation : CER, PER, CIR, literature reviews, meta-analyses, FDA, CE, MDR, IVDR submissions
→ Health authority interactions : FDA Pre-Submission, Notified Body responses
→ Biostatistics : study design, sample size, SAPs, agreement studies, equivalence testing, method comparison, survival analysis, diagnostic accuracy, imaging endpoints
→ SaMD/AI validation : diagnostic accuracy evaluation, algorithm benchmarking, 510(k) and CE support
Clients: Essilor Instruments (ophthalmic devices, 6+ product lines), Ligence & AIATELLA (cardiovascular AI SaMD : FDA, CE, MHRA), RetInSight/Topcon (retinal AI), OXcan (liquid biopsy IVD), ZOĪ (scientific publication), AP-HP (evidence synthesis).
Previously at Median Technologies (imaging CRO), point of contact for Roche, AstraZeneca, Merck, Amgen. Clinical Lead at Canon Medical Systems : multiple CE and FDA clearances.
Domains: clinical trials · medical devices · IVD · SaMD · regulatory affairs · biostatistics · scientific writing
Frameworks: MDR · IVDR · FDA 21 CFR · ICH-GCP · ISO 14155 · ISO 14971 · IEC 62304 · MEDDEV 2.7/1 · IMDRF SaMD · CLSI · MDCG · STARD · PRISMA
Frans
Tweetalig / moedertaal
Engels
Vloeiend
Arabisch
Tweetalig / moedertaal
Kan op locatie werken
Paris (tot 50km), Lyon (tot 50km), Toulouse (tot 50km), Bordeaux (tot 50km), Marseille (tot 50km)
Werkervaring
- Essilor InstrumentsFreelance Biostatistician & Clinical Research ConsultantPHARMACEUTISCHE INDUSTRIEoktober 2025 - april 2026 (6 maanden)Créteil, FrankrijkLed biostatistical support for ophthalmic medical device clinical investigations across 6+ product lines (dry eye, tonometry, biometry). Reviewed Designed clinical investigation protocols (CIP), developed SAPs, performed sample size calculations, and delivered statistical analyses for clinical investigation reports (CIR). Defined study endpoints, success criteria, and benchmarking strategy against predicate devices. Advised on clinical development strategy under ISO 14155, MDR 2017/745, and ICH-GCP. ISO 15004-1:2020SAPs, CIPs, CIRs, sample size justifications, statistical analyses.
- Confidential IVD ClientIVD Clinical DevelopmentBIOTECHNOLOGIEmaart 2026 - april 2026 (1 maand)Oxford, Verenigd KoninkrijkBiostatistical and clinical development support for a liquid biopsy based IVDEvaluated the statistical framework and diagnostic accuracy methodology against comparable IVD screening studies. Benchmarked study design against international regulatory expectations (FDA, IVDR).Contributed to Clinical Investigation Plan development for a global multicenter study (20+ healthcare centres, 3 continents).Ongoing project.
- ligence.ioFreelance Clinical Research Scientist : AI Cardiac SaMDMEDISCHE SECTORseptember 2025 - maart 2026 (6 maanden)Vilnius, LitouwenSupport clinical validation and regulatory compliance for Ligence Heart, contributing to preparation for FDA/CE/MDR certification.Define and manage clinical study protocols to validate AI-generated echocardiographic measurements.Perform data analysis, comparison vs. ground truth (expert reads), and statistical validation (accuracy, inter-observer variability, etc.).Collaborate with imaging engineers, software developers, and clinicians to refine model outputs and ensure alignment with cardiology standards.Author clinical documentation: Clinical Investigation Reports, validation reports, manuscripts, etc.Deliverables: CER, CIR, CIP, SAP, PEP, literature review, subgroup analyses, FDA and MDR/CE submission documentation.Ensure clinical safety monitoring and post-market surveillance design plans.Skills HighlightedClinical validation & study design (imaging / cardiology)Medical device / regulatory (FDA/EU MDR)Imaging data analysis & metrics (echocardiography)Collaboration with cross-functional technical & clinical teamsScientific & regulatory writing
# SaMD # FDA # MDR # MHRA # AI
Beoordelingen
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Opleidingen
- Doctor of Medicine (MD)University Badji Mokhtar ANNABA2015
- Master degree (Ms)University of Paris Diderot2017(ex BCPP) Bioinformatics Specialty path: Platform engineering in biology; https://www.mipfb.com/
Diploma's
- Good Clinical Practice TrainingAstra Nova Training2022
- DM regulation (MDR): from CE marking to placing on the marketIFIS - Institut de Formation des Industries de Santé2020