Market Overview

Intertek First Independent Lab in North America Accredited for End-to-End Evaluation of Implantable and Non-Implantable Medical Devices


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 60601-1-2 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.

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


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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