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:
- Magnetically induced displacement force (ASTM F2052)
- Image artifact (ASTM F2119)
- Radiofrequency-induced heating (ASTM F2182)
- Magnetically induced torque (ASTM F2213)
- Marking medical devices in the MR environment (ASTM F2503)
FDA Guidances:
- Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
- Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices
White Paper: Top 10 Challenges in Evaluating Medical Devices for MRI Safety
OUR COMMITMENT
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 4.98/5 points (9).