CSDmed Supports Keenamics in Innovating Ankle Rehabilitation
News
At CSDmed, we are proud to collaborate with Keenamics in developing innovative solutions for ankle rehabilitation. Leveraging our medical device expertise, we provide support at every stage of the project. Link to Eurasanté article.
About Keenamics and the Project
Keenamics is an innovative start-up, founded on the research of Professor Emilie Simoneau-Buessinger and Doctors Sébastien Leteneur and Christophe Gillet, dedicated to developing solutions for functional ankle rehabilitation. Their main project is a targeted rehabilitation medical device designed to improve recovery for patients suffering from complex ankle injuries or conditions. This device integrates cutting-edge technologies to adjust and personalize rehabilitation sessions, providing a faster and more efficient recovery. The goal is to combine biomechanical precision and patient comfort, facilitating a return to full mobility.
Our Role as Consultants
At CSDmed, we contributed in the following areas:
- Research and Development (R&D): Close ollaboration with Keenamics to optimize the device design.
- Quality Management: Implementation and monitoring of the Quality Management System (ISO 13485) to ensure product compliance and safety.
- Regulatory Affairs: Management of the regulatory requirements, including obtaining the CE marking under the EU MDR 2017/745.
Challenges Tackled
Developing such an innovative medical device presents several challenges:
- Compliance with stringent safety standards
- Integration of advanced technology for rehabilitation
- Clinical validation and testing to guarantee effectiveness
CSDmed leveraged its expertise and its partners expertise to address these complex demands and support Keenamics in achieving its goals.
Market Impact of the Project
The device in development by Keenamics is expected to significantly improve ankle rehabilitation for patients. Collaborations like these enable us to transform functional rehabilitation by bringing research and technology together for patient benefit.
Conclusion
Our partnership with Keenamics demonstrates our commitment to supporting innovation in the medical device sector. We look forward to seeing this device revolutionize ankle rehabilitation. Learn more in the Eurasanté article.
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European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).
CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the R&D dossiers, the QMS, the MDR Technical File in their entirety
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