There are several safety concerns for patients with metallic implants who require MRI, including magnetic interactions (i.e., force and torque) as well as radiofrequency-induced heating. We help medical device manufacturers evaluate their devices for safety in the MRI environment and perform physical MRI testing for magnetically induced displacement force, magnetically induced torque, MR image artifact, and RF-induced heating according to ASTM F2052, F2213, F2119 and F2182, respectively. After the testing is complete, we provide the necessary information for MRI safety labeling and supporting scientific rationale that is reported in the instructions for use (IFU) of the device according to ASTM F2503 and the FDA Guidance on establishing safety and compatibility of passive implants in the magnetic resonance environment.
We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 4.80/5 points (4).