Passionate experts in MedTech for more than 20 years, we support Swiss and French SMEs and start-ups on the steep path of placing or keeping medical devices on the market.
We can be involved as a service provider, consultant or resource for R&D, quality, clinical or regulatory teams.
Jean-François has more than 25 years of experience in medical devices. Trained as an engineer, his expertise covers product development, clinical research and quality assurance. His therapeutic knowledge includes orthopedics, spine, neurology, cardiology, and others, for devices from class I to III.
Trained on technical and scientific excellence in large groups and with practical experience in start-ups, he has particular expertise in risk management, QMS implementation and audit, scientific literature review and post-market clinical follow-up (PMCF). Over the last few years, he has developed an original platform for multiple post-market clinical studies, providing significant contributions to Clinical Evaluation Reports (CERs) or reimbursement files.
Christian has more than 20 years of experience in medical devices. He holds a Master and PhD in materials science and a Master’s degree in biomedical engineering. His areas of expertise cover product development, clinical studies, quality assurance and regulatory affairs. He has acquired solid knowledge in therapeutic areas such as orthopedics, spine, bone reconstruction, endodontics and periodontics.
He has many years of experience in creating technical documentation for CE marking and is particularly skilled in writing Clinical Evaluation Reports (CERs) and Biological Risk Assessments (BRAs). His recent activity as Director of Quality and Regulatory Affairs in an SME has especially led him to study the new 2017/745/EU Regulation in order to complete the transition from MDD to MDR.
Medalps SAS, 260 chemin de Poisan, 01220 Divonne-les-Bains, France – Société immatriculée au registre du commerce de Bourg-en-Bresse – SIREN 879687200
Medalps Sàrl, Route de Chailly 210, 1814 La Tour-de-Peilz, Suisse – Registre du commerce du Canton de Vaud – CHE-398.907.511
With our own experience in start-ups as well as in well-established MedTech companies, we bring expertise and creativity to help you achieve your objectives for placing a new device on the market, while training your team to ensure systems sustainability.
Contact us from the early design stage to ensure you avoid traps and take the right direction straight away, and maximize your chances of success!
You may not have the time or expertise to conduct literature searches, biohazard assessments, clinical evaluations, and write BRAs or CERs in a robust manner. We have a wide range of technical and scientific expertise to write them for you.
Regulation is complex and rapidly evolving. We can help you define a strategy and monitor its execution for the technical documentation, quality system, as well as PMCF and proactive PMS which are at the heart of the MDR new requirements.
In a remediation situation, following for instance a critical non-conformity detected during an external audit, we work with you to ensure device sustainability by proposing and participating in the implementation of an optimal solution.
