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.
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.