MRI Compatibility and Safety Testing
BDC Laboratories provides ISO/IEC 17025:2017-accredited MRI compatibility testing for passive medical devices, along with numerical modeling to support testing programs when appropriate. Numerical simulation and modeling guide the evaluation of a test article’s behavior within an MRI field, while physical testing confirms and quantifies its measured response.
With active participation in the ASTM standards committee for MRI assessment, BDC Laboratories’ experts offer insight into the challenges and nuances of MRI device evaluation.
While continuing to support the worldwide cardiac and endovascular communities with MRI safety testing, BDC Laboratories also provides MRI safety testing for orthopedic, spinal, dental, and other passive implant technologies.
Service Highlights
Standards-Driven Excellence
BDC Laboratories’ MRI compatibility and safety testing programs align with all applicable published standards listed below.
Custom Evaluation Options
Beyond executing MRI studies using predefined strategies, we routinely develop comprehensive evaluation strategies when one doesn’t exist.
Complete Testing Solution
Our team supports all aspects medical device corrosion assessment, including developing the testing strategy, establishing protocols, performing data analyses, and providing regulatory quality final reports.
Relevant Standards
ASTM Standards
- F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- F2119: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
- F2213: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
FDA Guidance
- 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
Testing Backed by ISO/IEC 17025 Accreditation
At BDC Laboratories, quality is central to everything we do. We maintain ISO/IEC 17025:2017 accreditation and comply with relevant portions of 21 CFR Part 58 (Good Laboratory Practices), among other U.S. and international governing standards. With a comprehensive quality management system, we ensure service and product integrity with a focus on regulatory compliance and continuous improvement.
Why BDC?
Built Around Your Goals
From first conversation to final report, we collaborate with your team to design and execute accredited testing programs aligned with your device goals and regulatory requirements.
Regulatory-Ready, On Time
With ISO/IEC 17025:2017 accreditation and 40+ years of industry experience, we deliver precise, regulatory-ready results on timelines that keep your project moving.
Reliable, Responsive Partnership
You’ll work with project managers who stay engaged throughout the process. They’re available for questions, quick to respond, and focused on keeping your program on track.
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Testing Services
Testing Equipment
Silicone Solutions
Simulation Solutions
Connect with an Expert at BDC
Provide a few details about your project, and a BDC Laboratories team member will respond within 2 business days to advise on next steps.