Gepromed
Gepromed is an organization dedicated to medical device expertise and research across various medical-surgical disciplines. It emphasizes continuous improvement in patient safety, innovation, and multidisciplinary collaboration. Certified with ISO 9001, ISO 13485, and Qualiopi, Gepromed conducts research, development, training, and analysis activities to advance medical device safety and efficacy.
Industries
Nr. of Employees
small (1-50)
Products
Surgical simulation platform and simulator prototypes
On-site simulation environments and custom-developed surgical simulators used for immersive training and technical skill development; also used as R&D demonstrators for device handling and procedural simulation.
Surgical simulation platform and simulator prototypes
On-site simulation environments and custom-developed surgical simulators used for immersive training and technical skill development; also used as R&D demonstrators for device handling and procedural simulation.
Services
Explant collection and analytical service
Reception, standardized preparation, imaging, histology and reporting for explanted medical devices; includes registration in a centralized database and optional advanced analyses.
Clinical research and CRO services for medical devices
End-to-end support for device-focused clinical studies including protocol design, regulatory dossier preparation, site initiation, monitoring visits, patient follow-up and data management for pre- and post-market investigations.
Device testing and mechanical evaluation
Independent testing services to assess mechanical performance of devices and constituent materials, performed according to certified quality processes.
Simulation-based training and certification courses
Hands-on surgical training programs using an on-site simulation center, blended with e-learning resources; programs target surgical residents and multidisciplinary OR teams.
Regulatory and quality advisory
Advisory support for compliance with EU MDR, ISO 13485/9001 and clinical standards (ISO 14155, GCP) and assistance in establishing quality systems for device testing and training activities.
Event and conference organization
Design and delivery of scientific meetings, symposia and hands-on bootcamps focused on biomaterials, device innovation and translational research.
Explant collection and analytical service
Reception, standardized preparation, imaging, histology and reporting for explanted medical devices; includes registration in a centralized database and optional advanced analyses.
Clinical research and CRO services for medical devices
End-to-end support for device-focused clinical studies including protocol design, regulatory dossier preparation, site initiation, monitoring visits, patient follow-up and data management for pre- and post-market investigations.
Device testing and mechanical evaluation
Independent testing services to assess mechanical performance of devices and constituent materials, performed according to certified quality processes.
Simulation-based training and certification courses
Hands-on surgical training programs using an on-site simulation center, blended with e-learning resources; programs target surgical residents and multidisciplinary OR teams.
Regulatory and quality advisory
Advisory support for compliance with EU MDR, ISO 13485/9001 and clinical standards (ISO 14155, GCP) and assistance in establishing quality systems for device testing and training activities.
Event and conference organization
Design and delivery of scientific meetings, symposia and hands-on bootcamps focused on biomaterials, device innovation and translational research.
Expertise Areas
- Explant analysis and forensic evaluation of implants
- Clinical trial management for medical devices
- Mechanical and materials testing for implantable devices
- Simulation-based surgical education
Key Technologies
- Surgical simulators and simulation environments
- Radiographic imaging for explants (faxitron-style)
- Histology and microscopic analysis
- Mechanical testing of medical devices