We evaluate the MRI safety and compatibility of your devices according to the latest international standards.
According to your needs and skills, our offer can be « turnkey » oriented or « custom-made » :
- « Turnkey » offer: We will take on everything, from the draft of the testing protocols to the support after the submission of a FDA dossier;
- « Custom-made » offer: you have in house MRI skills and wish to benefits from our expertise on specific topics.
Our services are structured according to ISO 17025. We guarantee high reactivity from our team, planning of our service and a regular reporting of your projects. And this is done while remaining completely confidential.
According to its quality policy, Healtis undertake to respect the recommendations and the international standards.
International standards for passive implantable medical devices :
- Measurement of magnetically induced displacement force in the static magnetic field: ASTM F2052
- Measurement of magnetically induced torque in the static magnetic field: ASTM F2213,
- Measurement of radio frequency induced heating on the device: ASTM F2182.
- Evaluation of image artifacts (according to ASTM F2119), with artifacts surface measurement.
- Device marking : ASTM F2503.
International standards for active implantable medical devices :
To get more information and a quotation, please contact us.