Several safety concerns exist when patients with metallic implants require diagnostic MRI. These concerns include magnetic forces, torques, radiofrequency-induced heating, gradient-induced heating and vibrations, unintended stimulation, and device malfunction. We help medical device manufacturers evaluate their devices for safety in the MRI environment and can perform physical testing according to ASTM F2052, F2213, F2119 and F2182. After the physical 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) for the device according to ASTM F2503 and the FDA guidance on establishing safety and compatibility of passive implants in the magnetic resonance environment.
Download the full whitepaper, “Top 10 Challenges in Evaluating Medical Devices for MRI Safety”, below.
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For client surveys sent in the last two quarters, we received ratings of 5/5 points (10).