MRI Safety Testing

HEALTIS offers comprehensive support to medical device manufacturers to qualify and improve their safety in the MRI environment. Our services include:

• ISO 17025* accredited testing to assess the MRI safety of medical devices.

• Interpretation of test results and assistance with device marking, in accordance with ASTM F2503*.

• Numerical modeling: risk prediction and identification of worst cases.

• Technical and regulatory assistance: definition of the relevant assessment strategies and justification of worst cases.

• Support for the design of MR-compatible devices.

• Specialized training on MRI medical device safety, tailored to R&D and regulatory affairs teams.

*HEALTIS is accredited by COFRAC, according to NF EN ISO/CEI 17025 (accreditation N° 1-6320, scope available on www.cofrac.fr).