Platform 01 · Engineering & testing
Engineering
Explant analysis, testing platform and equipment rental: a complete technical facility to assess the safety and performance of medical devices, from prototype to clinical feedback.
Explant analysis
Explant Analysis
Have an explanted device or any other sample analyzed by our biomaterials expertise platform.
Testing & characterization
Testing platform
Standardized and custom testing on textile materials and vascular implants, with personalized consulting-led support, to optimize the design of your devices.
Created in 2009 at the Strasbourg University Hospitals with the LPMT of the University of Haute-Alsace, the platform is an independent technical environment, operated under ISO 13485 and ISO 9001 certification since 2013.
Rental
Equipment Rental
Book our technical platforms and equipment for your own campaigns. Provide your desired date in the request.
FAQ
Frequent questions
What manufacturers and clinicians most often ask before entrusting us with a test or an explant.
Not in the sense of animal or human studies: Gepromed does not run those. Our platform tests the devices themselves, through tensile, radial force and fatigue testing, and analyzes explanted devices.
Regulation (EU) 2017/745, Annex II, section 6.1(a), lists among preclinical data "results of tests, such as engineering, laboratory, simulated use and animal tests". The mechanical tests performed on our benches fall into the first category.
Our tests primarily serve design: comparing two options, locating a limit, optimizing a device. The resulting data can then feed the manufacturer's technical documentation, for which the manufacturer remains responsible. The platform has been operated under ISO 13485 and ISO 9001 certification since 2013.
The examination of a device removed from a patient, with or without a complication. The analysis covers failure characterization, device degradation and clinical feedback. It relies on radiographic and tomographic imaging, microscopy, surface analysis and histology.
- Longitudinal and circumferential tensile testing
- Radial force: loading and unloading behavior of stents and endoprostheses under simulated physiological pressure, at 37 °C
- In vitro fatigue testing, to assess device durability under clinically representative conditions
- Custom test benches, designed with manufacturers and clinicians
Yes. We design custom test benches in close collaboration with the client, to assess innovative performance or simulate extreme conditions of use, situations that standard normative tests do not always cover.
Yes. Our technical platforms and equipment can be booked for your own test campaigns. State your preferred date in the request.