Intertek Granted ASCA Recognition by U.S. Food and Drug Administration for Premarket Testing of Medical Devices
13 Abril 2021 - 9:15AM
Business Wire
Intertek, a leading Total Quality Assurance provider to
industries worldwide, has been selected as an accredited testing
laboratory under the U.S. Food and Drug Administration (FDA)
Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Program. With this recognition, 12 Medical Centers of Excellence
within Intertek’s global network of labs are authorized to assist
manufacturers around the world with medical device premarket
testing to access the U.S market.
The ASCA Pilot Program is a voluntary program developed to
provide increased confidence in testing results, allowing for
greater consistency and predictability in the FDA's approach to
conformity assessment. Following a two-step application and
evaluation process, Intertek was granted accreditation for the
program. As a recognized lab, the Company is approved to conduct
assessments on medical devices for conformity to recognized
consensus standards and test methods used in premarket reviews,
delivering comprehensive test reports along with ETL Certification
and CB Scheme Reports.
Sunny Rai, Senior Vice President at Intertek, commented: “At
Intertek, our focus has always been on providing Total Quality
Assurance solutions to our customers, helping them navigate the
testing and certification process. This accreditation will help
provide peace of mind to the industry and support the FDA’s
continued public health mission. We are thrilled to build upon our
years of experience and expertise to help decrease the burden of
premarket submissions, making the process smoother and ultimately
getting products to market as quickly and efficiently as
possible.”
For more than 50 years, Intertek has been partnering with
medical device manufacturers to provide 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 12 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.
ABOUT INTERTEK
Total Quality. Assured.
Intertek is a leading Total Quality Assurance provider to
industries worldwide. Our network of more than 1,000 laboratories
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.
intertek.com
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FOR MEDIA INFORMATION: Please contact Cheryl
Prejsnar US PR Manager +1 630-408-5538 cheryl.prejsnar
@intertek.com
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