Past collaborations
Past collaborations
Clinical strategy. Compliance. Results.
Clinical strategy. Compliance. Results.
Your expert in clinical development and regulatory compliance for Medical Devices.
Your expert in clinical development and regulatory compliance for Medical Devices.
Class I to III
AI, electronic, implantable...
+8 years of passion
Class I to III
AI, electronic, implantable...
+8 years of passion
Class I to III
AI, electronic, implantable...
+8 years of passion
Turn your clinical projects into success stories: performance, compliance, and data valorization at the heart of your clinical strategy.
Turn your clinical projects into success stories: performance, compliance, and data valorization at the heart of your clinical strategy.
Expertise at Your Service
Comprehensive support to drive innovation, ensure compliance, and accelerate your medical device development.
Tailored Clinical Strategy
Tailored Clinical Strategy
Design and support of your clinical development and validation plans, including AI-based, electronic, and implantable medical devices.
Clinical Study Design & Management
Clinical Study Design & Management
End-to-end support for planning, execution, operational oversight, and regulatory submission of your clinical investigations.
Clinical Investigation Monitoring
Clinical Investigation Monitoring
Monitoring services including site initiation, routine visits, and close-out visits, in full compliance with Good Clinical Practice (GCP).
Clinical Evaluation
Clinical Evaluation
Comprehensive support for the preparation of all clinical evaluation documentation compliant with MDR and other applicable regulations.
Regulatory Compliance
Regulatory Compliance
Audits, consulting, and writing of documents ensuring compliance with MDR, ISO 14155, and GDPR requirements.
Process Optimization
Process Optimization
Improvement of your clinical workflows—from data collection and analysis to clinical evidence generation—adapted for AI-integrated technologies.
Training
Training
Training sessions on clinical best practices (e.g., ISO 14155, GDPR) and clinical evaluation (MDR, MDCG)
GDPR Compliance
GDPR Compliance
Provide guidance and operational support to help you assess, document, and align your data processing activities.
On-Demand Support
On-Demand Support
Flexible support when and where you need it.
Whether for a short-term boost or long-term collaboration, we offer tailored clinical support to meet your specific needs at any stage of your project.
Expertise at Your Service
Comprehensive support to drive innovation, ensure compliance, and accelerate your medical device development.
Tailored Clinical Strategy
Design and support of your clinical development and validation plans, including AI-based, electronic, and implantable medical devices.
Clinical Study Design & Management
End-to-end support for planning, execution, operational oversight, and regulatory submission of your clinical investigations.
Clinical Investigation Monitoring
Monitoring services including site initiation, routine visits, and close-out visits, in full compliance with Good Clinical Practice (GCP).
Clinical Evaluation
Comprehensive support for the preparation of all clinical evaluation documentation compliant with MDR and other applicable regulations.
Regulatory Compliance
Audits, consulting, and writing of documents ensuring compliance with MDR, ISO 14155, and GDPR requirements.
Process Optimization
Improvement of your clinical workflows—from data collection and analysis to clinical evidence generation—adapted for AI-integrated technologies.
Training
Training sessions on clinical best practices (e.g., ISO 14155, GDPR) and clinical evaluation (MDR, MDCG)
GDPR Compliance
Provide guidance and operational support to help you assess, document, and align your data processing activities.
On-Demand Support
Flexible support when and where you need it.
Whether for a short-term boost or long-term collaboration, we offer tailored clinical support to meet your specific needs at any stage of your project.
Who am I?
Driven by passion, obstacles are transformed into challenges and opportunities. Indeed, I firmly believe that the clinic is not a brake but an elevator for its scientific, marketing and economic medical device.
· Master’s Degree in Health Engineering, specialized in Methods for Designing and Managing Clinical Research Projects (France)
· University Diploma (DU) in Medical Device Regulatory Affairs – Université Paris Cité (2026)
· Over 8 years of experience in the medical device industry, in Clinical and Regulatory Affairs, including project management and consulting
· Independent Medical Device Consultant – Founder of PeliClinic
· University Lecturer in Clinical Research and Medical Devices
· Support for CE marking and maintenance of regulatory compliance under the EU MDR (2017/745) throughout the medical device lifecycle
· Clinical and regulatory strategy, from product development and pre-market activities to post-market surveillance
· Clinical investigations (pre- and post-market): study strategy and design, regulatory and ethics submissions, study documentation, monitoring and follow-up
· Clinical Evaluation: Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), literature reviews, equivalence/similarity strategies and clinical evidence assessment
· Post-Market Clinical Follow-up (PMCF) & Post-Market Surveillance (PMS): PMCF Plans and Reports, PMS Plans and Reports, PSUR, vigilance and trend reporting
· Regulatory and Quality support: regulatory documentation, notified body responses, clinical/regulatory gap assessments, procedures and QMS documentation
· Experience with Class I to Class III medical devices, including implantable devices and medical device software
· Areas of experience:
Dental and maxillofacial surgery
Orthodontic devices
Medical imaging and ultrasound
Dental prosthetics
Bone substitutes
Medical device software and AI-based solutions
· Experienced in collaboration with manufacturers, healthcare professionals, investigators, Key Opinion Leaders (KOLs), competent authorities, ethics committees and notified bodies
· Strong expertise in EU MDR clinical requirements and clinical evidence throughout the medical device lifecycle
Who am I?
Driven by passion, obstacles are transformed into challenges and opportunities. Indeed, I firmly believe that the clinic is not a brake but an elevator for its scientific, marketing and economic medical device.
· Master’s Degree in Health Engineering, specialized in Methods for Designing and Managing Clinical Research Projects (France)
· University Diploma (DU) in Medical Device Regulatory Affairs – Université Paris Cité (2026)
· Over 8 years of experience in the medical device industry, in Clinical and Regulatory Affairs, including project management and consulting
· Independent Medical Device Consultant – Founder of PeliClinic
· University Lecturer in Clinical Research and Medical Devices
· Support for CE marking and maintenance of regulatory compliance under the EU MDR (2017/745) throughout the medical device lifecycle
· Clinical and regulatory strategy, from product development and pre-market activities to post-market surveillance
· Clinical investigations (pre- and post-market): study strategy and design, regulatory and ethics submissions, study documentation, monitoring and follow-up
· Clinical Evaluation: Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), literature reviews, equivalence/similarity strategies and clinical evidence assessment
· Post-Market Clinical Follow-up (PMCF) & Post-Market Surveillance (PMS): PMCF Plans and Reports, PMS Plans and Reports, PSUR, vigilance and trend reporting
· Regulatory and Quality support: regulatory documentation, notified body responses, clinical/regulatory gap assessments, procedures and QMS documentation
· Experience with Class I to Class III medical devices, including implantable devices and medical device software
· Areas of experience:
Dental and maxillofacial surgery
Orthodontic devices
Medical imaging and ultrasound
Dental prosthetics
Bone substitutes
Medical device software and AI-based solutions
· Experienced in collaboration with manufacturers, healthcare professionals, investigators, Key Opinion Leaders (KOLs), competent authorities, ethics committees and notified bodies
· Strong expertise in EU MDR clinical requirements and clinical evidence throughout the medical device lifecycle
Discover my YouTube channel
You will find short, practical, and accessible videos covering key topics such as Clinical Investigation, Different types of clinical studies in France, …
👉 Access the channel here: Peliclinic on YouTube
Explore My Writings
Insights, reflections, and practical analysis on clinical affairs in the medical device industry.
Explore My Writings
Insights, reflections, and practical analysis on clinical affairs in the medical device industry.
What My Partners Say
Real-life experiences of professionals I have worked with.
“I've had the pleasure to work with Ludovic on several projects, and I'd like to highlight his rigour, expertise, and remarkable adaptability. He's always shown great composure and optimism in every situation he's had to deal with, without ever compromising the quality of the results delivered or his good working relationships with other team members.”
“I've had the pleasure to work with Ludovic on several projects, and I'd like to highlight his rigour, expertise, and remarkable adaptability. He's always shown great composure and optimism in every situation he's had to deal with, without ever compromising the quality of the results delivered or his good working relationships with other team members.”
Head of Clinical Affairs / Regulatory, Start-up, Class IIa Electronic Medical Device
“Excellent communication throughout the collaboration. We appreciated the pragmatic and regulatory-aligned advice.”
“Excellent communication throughout the collaboration. We appreciated the pragmatic and regulatory-aligned advice.”
R&D Director, Mid-size MedTech company
“A clear, structured, and proactive approach. Their support was key during our MDR clinical documentation update for our custom-made medical devices.”
“A clear, structured, and proactive approach. Their support was key during our MDR clinical documentation update for our custom-made medical devices.”
RA/QA Manager, Class IIa device manufacturer
“Working with Ludovic has been invaluable. His deep understanding of clinical protocols and regulatory requirements ensured that our clinical investigations ran smoothly and fully complied with applicable standards. I highly recommend his expertise to any medical or clinical team seeking reliable support.”
“Working with Ludovic has been invaluable. His deep understanding of clinical protocols and regulatory requirements ensured that our clinical investigations ran smoothly and fully complied with applicable standards. I highly recommend his expertise to any medical or clinical team seeking reliable support.”
Professor of Radiology, Necker Children's Hospital, Paris