Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said this week.
The accreditation authorizes Intertek’s 12 “medical centers of excellence” to perform premarket testing of devices for the U.S. market.
The Accreditation Scheme for Conformity Assessment 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. As a recognized lab, Intertek is approved to conduct assessments on medical devices for conformity to recognized consensus standards and test methods used in premarket reviews, delivering test reports along with ETL Certification and CB Scheme Reports.
“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,” said Intertek SVP Sunny Rai in a news release. “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.”
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Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/Qg05-V4Tff0/)
