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MEDICAL & SCIENTIFIC AFFAIRS CONSULTANT -R&D MD, msc

Profile Summary

Scientific and regulatory consulting for MedTech, pharmaceutical, IVD, and AI-driven diagnostics companies. Physician-scientist (MD, MSc Bioinformatics) with 9+ years of experience at the intersection of clinical research, biostatistics, and regulatory science across the medical device, diagnostics, and digital health industries. I provide end-to-end scientific and regulatory consulting for medical devices, AI-based Software as Medical Devices (SaMD), and in vitro diagnostics (IVD), supporting companies from clinical development strategy through regulatory submission. Core expertise: • Clinical study design and execution: clinical investigation protocols (CIPs), statistical analysis plans (SAPs), sample size calculations, and clinical investigation reports (CIRs) under ISO 14155, MDR xxxxxxxx, and ICH-GCP • AI/SaMD clinical validation: diagnostic performance evaluation (sensitivity, specificity, AUC, NPV/PPV), algorithm validation against reference standards, and regulatory documentation for CE marking and FDA 510(k) submissions • Regulatory scientific documentation: clinical evaluation reports (CER/MDR), performance evaluation reports (PER/IVDR), literature reviews, and responses to Notified Body and health authority queries • Biostatistics and data science: advanced statistical modeling, real-world evidence analysis, and scientific publication support Recent and current projects include ophthalmic device clinical investigations (Essilor Instruments: dry eye, tonometry, biometry), AI-based retinal imaging software (RetInSight/Topcon : OCT-based SaMD for retinal disease monitoring), AI-powered cardiovascular diagnostic SaMD (Ligence, AIATELLA:FDA and CE/MDR submissions), diagnostic imaging software (Olea Medical/Canon Medical Systems), liquid biopsy IVD for lung cancer screening, and a peer-reviewed scientific publication on predictive biological aging models (ZOĪ). Therapeutic areas: ophthalmology, cardiovascular diagnostics, oncology, neurology, women's health, aging/longevity. I work as an independent consultant, fully remote, with the flexibility to support projects on a part-time or full-time basis across European and international time zones.

Subject Matter Expertise

• ☆ Biostatistics
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Market Research, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting

Data & AI Predictive Modeling, Statistical Analysis, Image Processing, Image Analysis, Algorithm Design-ML, Data Visualization, Big Data Analytics, Data Cleaning, Data Processing, Data Insights

Work Experience

Medical Statistician, Writer and Biomedic Consultant

IVD Clinical Development & Regulatory Support (OXcan / Anatomise Biostats)

February 2026 - April 2026

Clinical Investigations & Biostatistics (Essilor Instruments)

Essilor Instruments

October 2025 - April 2026

Clinical Trial Design, Management & Reporting

Ligence

September 2025 - April 2026

Clinical Research & Regulatory Submissions

AIATELLA

July 2025 - March 2026

Scientific Content Creation & Biomarker Research

ZOĪ

May 2025 - December 2025

Clinical Research Scientist

Median Technologies - iCRO - Clinical Affairs

August 2022 - February 2025

Research Engineer - Expert Doctor (Clinical Referent)

OLEA MEDICAL - Canon Medical Systems Corporation

April 2019 - July 2022

Research Engineer

The Brain and Spinal Cord Institute - Pitié-Salpêtrière hospital - Neuroimaging Research Center

July 2016 - April 2019

Education

Masters of Science

Université Denis Diderot (Paris VII) - France

September 2015 - July 2017

Medical Degree (MD)

Université Badji Mokhtar - Algeria

September 2007 - September 2015

Certifications

• Good Clinical Practice training

  Astra nova

  August 2022 - September 2022

• DM regulation (MDR): from CE marking to placing on the market

  IFIS

  February 2022 - February 2022

• Knowledge Verification Tests (EVC) - PAE

  CNG

  https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000041554399

  December 2019 - February 2020

Publications

JOURNAL ARTICLE

Mehdi Felfli, Sebastien Jacques, Alexandre Thinnes, Antoine Iannessi (2025). Using tumor growth modeling and informed neural networks as early predictive clinical endpoints . Journal of Clinical Oncology.

Mehdi Felfli, Alexandre Thinnes, Sebastien Jacques, Yan Liu, Antoine Iannessi (2024). Assessing immunotherapy response: going beyond RECIST by integrating early tumor growth kinetics . Frontiers in Immunology.

Mehdi Felfli, Yan Liu, Fadila Zerka, Charles Voyton, Alexandre Thinnes, Sebastien Jacques, Antoine Iannessi, Sylvain Bodard (2023). Systematic Review, Meta-Analysis and Radiomics Quality Score Assessment of CT Radiomics-Based Models Predicting Tumor EGFR Mutation Status in Patients with Non-Small-Cell Lung Cancer . International Journal of Molecular Sciences.

Mehdi Felfli, Yan Liu, Sylvain Bodard, Fadila Zerka, Charles Voyton, Alexandre Thinnes, Sebastien Jacques, Antoine Iannessi (2023). Multicenter evaluation of AI-based CT radiomics for EGFR mutation prediction in NSCLC . Journal of Clinical Oncology.

Mehdi Felfli, Yan Liu, Fadila Zerka, Sylvain Bodard, Charles Voyton, Alexandre Thinnes, Sebastien Jacques, Antoine Iannessi (2023). CT based radiomics signature for phenotyping histopathological subtype in patients with non-small cell lung cancer . Journal of Clinical Oncology.

Mehdi Felfli, Nadège Sarrazin, Estelle Chavret-Reculon, Corinne Bachelin, Rafik Arab, Sophie Gilardeau, Elena Brazhnikova, Elisabeth Dubus, Lydia Yahia Cherif, Jean Lorenceau, et al. (2022). Failed remyelination of the nonhuman primate optic nerve leads to axon degeneration, retinal damages, and visual dysfunction . Proceedings of the National Academy of Sciences.

Mehdi Felfli, Ioana Hill, Marco Palombo, Mathieu Santin, Francesca Branzoli, Anne-Charlotte Philippe, Demian Wassermann, Marie-Stephane Aigrot, Bruno Stankoff, Anne Baron-Van Evercooren, et al. (2021). Machine learning based white matter models with permeability: An experimental study in cuprizone treated in-vivo mouse model of axonal demyelination . NeuroImage.

Mehdi Felfli, Vincent Perlbarg, Justine Lambert, Benjamin Butler, Romain Valabrègue, Anne-Laure Privat, Stéphane Lehéricy, Alexandra Petiet (2018). Alterations of the nigrostriatal pathway in a 6-OHDA rat model of Parkinson’s disease evaluated with multimodal MRI . PLOS ONE.

PREPRINT

Mehdi Felfli, Fadila Zerka, Charles M Voyton, Alexandre Thinnes, Sebastien Jacques, Yan Liu, Antoine Iannessi (2024). A CT-based radiomics approach for CD8+ lymphocytes infiltration stratification in patients with non-small cell lung cancer .