Intertek First Independent Lab in North America Accredited for End-to-End Evaluation of Implantable and Non-Implantable Medical Devices
August 16, 2018
Boston – Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce that it has been accredited by the American Association for Laboratory Accreditation (A2LA) at its Boxborough, Massachusetts laboratory to test active implantable medical devices (AIMDs) to ISO 14708-1 and EN 45502-1 standards. With this, Intertek becomes 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 U.S. 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 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.
Sunny Rai, Senior Vice President at Intertek, commented: “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.”
For more than 50 years Intertek has been partnering with medical device manufacturers to deliver Total Quality Assurance solutions for Assurance, Testing, Inspection and Certification. The Company's experts understand the latest technologies and the regulatory requirements that products must meet, including those for mobile health applications and software. With engineers and technicians at 10 Centers of Excellence and 23 labs across the world dedicated to testing medical devices equipped with state-of-the-art equipment, Intertek helps customers launch new medical devices to market quickly. For more information, visit www.intertek.com/medical.
Total Quality. Assured.
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.
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