Good Laboratory Practice (GLP) compliance obtained by IHU Strasbourg

Good Laboratory Practice (GLP) compliance obtained by IHU Strasbourg

The University Hospital Institute (IHU) of Strasbourg has become the first French facility to obtain recognition of compliance with good laboratory practice for the preclinical evaluation of medical devices.

Operating room of the experimental platform at the IHU Strasbourg

Operating room of the experimental platform at the IHU Strasbourg © IHU Strasbourg

Recognition by the ANSM

On October 21, following over two years of work, the French National Agency for the Safety of Medicines and Health Products (ANSM) awarded the Image-Guided Surgery Institute of Strasbourg recognition of compliance with Good Laboratory Practices. This recognition concerns implantable medical devices (vascular or digestive stents, surgical clips, prostheses) and diagnostic or treatment assistance devices, both hardware and software, including systems based on Artificial Intelligence.

The IHU in Strasbourg is the first academic institute in France, and one of the very first in Europe to obtain this recognition.

A guarantee for Industry

Certification of GLP compliance sets the IHU of Strasbourg apart from its peers for industry partners and collaborators. It allows them to simplify and accelerate their own accreditation processes, but also to test products before they are approved. Valid on the European market (CE marking), but also in all OECD member countries including the USA (FDA) and Japan, the accreditation represents the Industry’s confidence in trusting the IHU’s preclinical expertise.

An experimental platform and network of experts that are unique in the world

Une plateforme expérimentale et un réseau d’experts unique au monde

The IHU’s experimental platform is fitted with cutting-edge equipment in the fields of surgery, imaging, and minimally invasive therapies (flexible endoscopy, endovascular or percutaneous treatments, robot-assisted surgery). Since its creation, over fifty industry or academic laboratory professionals have been able to work in this platform in a wide range of fields, from hepato-gastroenterology, to cardiovascular studies, neurology and neurosurgery, as well as urology, interventional pneumology, thoracic surgery, gynaecology, and orthopaedics. By coming to the IHU in Strasbourg, manufacturers benefit from the expertise and tailor-made services of an internationally recognized research institute to test and verify the safety and expected effectiveness of their medical devices.

According to IHU Director, Benoît Gallix, “The recognition of GLP compliance should enable us to double this contracted research for industry professionals within two years”.

Customized services to meet the needs of the market

We provide tailor-made services to meet the needs of our customers. We accompany them from the preparation of their research plan by advising them on the experiments most suited to meeting their objectives and go as far as providing them with a complete report that can include a file for submissions to regulatory authorities.

Our experts are personally involved in these studies so as to contribute their knowledge and expertise and may also participate in the improvement of the product or the procedure thanks to their experience feedback.

The services we offer also apply to the organization of training sessions with industrial customers to train practitioners in the use of a new medical device or a new therapeutic approach. More particularly, we have a catalogue of preclinical in vivo and ex vivo models that we can adapt to the needs of our customers (catalogue provided on request) for a tailor-made course, adapted to the specificities of the device.

Télécharger la brochure de la plateforme expérimentale (en anglais)Download the brochure of the experimental platform

Read the press release – 08/11/2021 by Noiizy

ENSIST: A new collaboration between InSimo and IHU Strasbourg, supported by the Region Grand Est

ENSIST: A new collaboration between InSimo and IHU Strasbourg, supported by the Region Grand Est

In partnership with the IHU Strasbourg, InSimo has embarked on the development of simulation modules dedicated to learning new surgical techniques using endoscopy approach with the launching of the ENSIST project supported by the Grand Est Region. The simulation modules will be carried through with the IHU Strasbourg, allowing ENSIST to lay a solid foundation for collaboration with a view to building a close and long-lasting partnership. Through this project, InSimo will benefit from the input of medical experts from the institute who will support its development from defining training needs to the implementation of training, and will validate the pedagogical value of the simulator.

The development of the two simulation modules will be supervised by Prof. Lee Swanström, Director of Innovation (IHU Strasbourg) and Prof. Silvana Perretta, Director of Education (IHU Strasbourg). Therefore, through this partnership, InSimo will be able to count on the support of the institute’s resources for the management of preclinical and clinical research with a study that will be conducted to validate patient-specific simulation of stomach deformation.


Photo credit: InSimo

In 2020, the ENSIST project won the R&D&I scheme set up to support collaborative R&D and innovation projects.
This project has the support of the Grand Est Region, BioValleyFrance and BPI France providing significant support for a project estimated at over a million euros.

For more information, the press release in English