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MRI Safety

Magnetic resonance imaging (MRI) testing of medical devices

There are several MRI safety concerns for patients with metallic implants, including magnetic interactions (i.e., force and torque) as well as radiofrequency-induced heating. We can evaluate your device 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. After the testing is complete, we will provide the necessary information for MRI safety labeling and supporting scientific rationale that is reported in the instructions for use (IFU) of your device.

Our scientists are part of the ASTM standard working groups for MRI testing and have direct interaction with regulatory bodies on a regular basis to ensure that we’re always informed of new testing requirements. We are also active in publications and research.

Standardized Tests:

FDA Guidances:

White Paper: Top 10 Challenges in Evaluating Medical Devices for MRI Safety