Exponent MRI Laboratory Receives ISO/IEC 17025 Accreditation from A2LA

Exponent's biomedical engineering and sciences laboratory in Philadelphia is now ISO/IEC 17025 certified by the American Association for Laboratory Accreditation (A2LA, Certificate #2561.01) per ISO/TS 10974:2018 "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device."

Exponent's Philadelphia laboratory has long offered MRI safety assessment as a core service and has been accredited for MRI safety evaluation for passive devices since 2007. These new methods are for assessing active devices, such as nerve stimulators and pacemakers, that rely on feedback from the body to deliver therapies and typically have onboard battery power.

The latest test method additions to the scope of accreditation include: 

While Exponent consultants collaborate with regional imaging facilities to use patient MRI systems to comprehensively evaluate device-related risks, these new methods could not be developed without the new radiofrequency (RF) and gradient coils recently installed and validated in the Philadelphia laboratory. These coils were used to develop many of the active device evaluation procedures and are intended to provide highly repeatable worst-case conditions that patients may experience when in the MRI environment.

An internationally recognized third-party accreditation body, A2LA performs unbiased and objective evaluations and has assessed Exponent's methods per the requirements of ISO/IEC 17025. ISO/IEC 17025 accreditation allows Exponent's team to rapidly complete the supplier approval procedures expected by medical device manufacturers and provides increased confidence in the results obtained from testing conducted under validated and continuously improved procedures.

Exponent's consultants draw on their technical experience to assess patient-implant risks in the context of client-provided indication and device information and then use the accredited procedures to quantify the potential risks to the patient in the MRI scanner. Ultimately, the results are used to develop industry standard labels to meet regulatory requirements and serve to communicate patient risks to MRI scanner operators around the world.