MRI safety and compatibility testing

We offer a wide range of tests for evaluating the safety of medical devices in the MRI environment, here is a non-exhaustive list:

Each device is unique, and our expertise allows us to adapt to most situations. We design and carry out tailor-made tests to meet any particular demand, especially when the normative methods are not directly applicable (non-implantable devices for example). So contact us to discuss your project.

Quality commitment

Our quality policy allows us to guarantee the reliability of our test results and the conformity of our practices with the normative requirements.

HEALTIS is ISO/IEC 17025 accredited (accreditation N° 1-6320, scope available on www.cofrac.fr).

Benefit from our support!

You will be in touch with one of our experts from the first contact. They will communicate with you all of the necessary information to understand the foundations of our business and the relevant regulatory framework. They will take into account your needs to bring you an adapted response to your inquiry.

Throughout the realization of your project we guarantee a cleat communication and strong support. You will have all the information you need to understand our work and if you wish, may attend the realization of your tests.

Where necessary, our numerical modeling and technical and regulatory assistance activities will assist you in defining a relevant risk assessment strategy, identifying and justifying the worst cases, interpreting test results, and ensuring the labelling of your products according to ASTM F2503 and the relevant literature.
To learn more about the safety and compatibility of medicals devices in MRI, you also have the opportunity to participate in our trainings.

Optimum means of testing

Your tests will be performed on MRIs, by qualified engineers, PhDs or test technicians.
Our instruments are selected or designed by our team of experts to meet all the constraints of the MRI environment and the normative requirements. All instruments are qualified, calibrated and regularly monitored.

We additionally have available a probe for measuring signals during an MRI exam; this allows, for example, to monitor the activity of an active implant in the MRI environment during an MRI exam.

An Experienced Laboratory

HEALTIS has performed safety and MRI compatibility tests on a large number of implantable and non-implantable devices. Which, for the most part, have been introduced to the US, European, or Asian markets.More than 500 trials have already been conducted in our laboratory for clients from all backgrounds and a variety of devices. Here are some examples of devices we have tested: