Total Quality Assurance provider, Intertak Granted ASCA Recognition

Intertek is a leading Total Quality Assurance provider to various industries across the world. It an accredited testing laboratory under the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The ASCA pilot program is a voluntary program that provides confidence in testing results.

The program allows for greater predictability and consistency in the FDA’s approach to conformity assessment. The two-step application and evaluation process was done after which Intertek was granted accreditation for the program. Being a recognized lab, it has been approved to conduct assessments on medical devices for conformity to recognize the consensus standards and test methods used for premarket reviews.

Senior Vice President at Intertek, Sunny Rai, 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 above 50 years, the company has been partnering with many medical device manufacturers to provide Assurance, Inspection, Certification, and Testing. The latest technologies and the regulatory requirements that products need to meet are known by the company’s experts including mobile health applications and software. Engineers and technicians at 12 Centers of Excellence and 23 labs across the world dedicated to testing medical devices equipped.