The lab, run by London-based Intertek, has been accredited by the American Association for Laboratory Accreditation (A2LA) to test active implantable medical devices (AIMDs) to ISO 14708-1 and EN 45502-1 standards. This makes it the first independent laboratory in North America accredited for electrical safety and electromagnetic compatibility (EMC) testing for both implantable and non-implantable medical devices.
Active implantable medical devices rely on a source of power other than what is provided by the body or gravity, and are intended to be surgically/medically inserted into the body and remain there after the procedure. As one of the highest risk categories of medical devices they are subject to rigorous regulatory standards by the US Food and Drug Administration (FDA) and other authorities around the world. To reduce risk and ensure quality, medical device manufacturers choose to work with a third-party laboratory to illustrate compliance with these electrical safety, EMC and wireless standards.
Most active implantable devices consist of both the product inserted into the body and non-implantable supporting equipment, both of which require testing and evaluation to medical regulatory standards, including IEC 60601-1-2 3rd Edition for non-implantable devices and components. With the new accreditations, Intertek now offers fully-accredited electrical safety, EMC and wireless device testing and evaluation services for both implantable and non-implantable products, with one all-encompassing report to be submitted to the FDA or other notified bodies. This in turn can help reduce costs and allow customers to get products to market faster.
“At Intertek, our focus has always been to provide innovative Assurance, Testing, Inspection and Certification services to our customers to help them bring their products to market quickly, efficiently and safely. We are thrilled to offer the medical device industry the evaluation they need for active implantable devices in one location with a team of highly proficient experts who are familiar with the necessary requirements for this growing medical field,” said Sunny Rai, Senior Vice President at Intertek.
The company has engineers and technicians at 10 Centres of Excellence and 23 labs across the world dedicated to testing medical devices.