Between the engineering phase and the device’s arrival at the patient’s bedside lies a critical step: validating the medical device’s safety and efficacy. To navigate this demanding regulatory hurdle without slowing down the development timeline, the IHU Strasbourg offers innovators its expertise and a preclinical testing platform—unique in Europe—for surgery and interventional medicine.
A phased testing protocol, from virtual models to real operating room conditions
The institute offers support throughout the entire nonclinical evaluation cycle. Technologies are validated there from the early design phases using advanced simulation models, anatomical phantoms, ex vivo models, and synthetic and biological tissues. This iterative approach allows for adjustments to the ergonomics of instruments, ensures the reliability of surgical procedures, and tests the integration of imaging systems well before formal regulatory stages.
For advanced in vivo validation phases, the IHU has an unparalleled infrastructure: five experimental operating rooms configured as exact replicas of the institute’s clinical operating rooms. Equipped with interventional CT and MRI scanners, as well as a robotic C-arm, the platform brings together a multidisciplinary team on a daily basis, comprising surgeons, veterinarians, engineers, and human factors specialists. This collaborative effort ensures that trials are conducted under conditions that are strictly identical to those of human surgical practice.
The GLP Certification: A Passport to European and U.S. Markets
In a regulatory environment strengthened by the European Medical Device Regulation (MDR), the robustness of preclinical data directly determines market access. The IHU Strasbourg was the first French research center certified as compliant with Good Laboratory Practices (GLP) for the nonclinical evaluation of medical devices, a certification renewed in 2023 and 2025.
This compliance gives the studies international legal validity: the reports produced can be directly incorporated into CE marking dossiers as well as into regulatory submissions to the U.S. FDA, which has already audited and validated several protocols conducted in Strasbourg.
With more than 160 industrial studies conducted to date, the preclinical platform serves as a trusted third party for international MedTech startups and manufacturers, transforming laboratory prototypes into solutions ready for the operating room.
To learn more:
- Learn more about the equipment and protocols of our preclinical department.
- A closer look at the institute: Read the articles and team testimonials in the special issue of *Or Norme* dedicated to the IHU Strasbourg.
