MED Institute, a contract research organization, received designation as an accredited ISO/IEC 17025 laboratory as part of the FDA Accreditation Scheme for Conformity Assessment (ASCA). FDA launched the ASCA Pilot Program in support of FDA’s public health mission to provide increased confidence, consistency and predictability for medical device safety and performance testing. To be eligible for this program, testing laboratories must be accredited to ISO/IEC 17025 and have additional ASCA reporting guidelines in place.
The intent of the ASCA program is to enhance confidence in medical device testing. As a result, this voluntary program may decrease the regulatory submission burden on manufacturers who select ASCA accredited testing laboratories to perform testing in conformance with FDA-recognized consensus standards and test methods.
MED Institute has always recognized that demonstration of competence and use of validated methods are a large part of increasing confidence in device testing, and looks forward to expansion of this program to include other testing standards.
“We have a long history of being on the leading edge of standardization and accreditation including involvement in global ISO and ASTM standards, as well as maintaining our own ISO/IEC 17025 accreditation since 2004”, says Justin Metcalf, Director of Engineering Services at MED Institute. “Quality is at the heart of our company and we continue to demonstrate this by involvement in this FDA Pilot program”.
The benefits of MED Institute having this Accreditation include:
- Providing a means for a potential decrease in individual premarket submissions for our clients;
- Having access to input from experts across the medical device manufacturing and standards conformity assessment communities; and
- Generating increased confidence in testing results.
MED Institute supports entrepreneurs, consultants, developers and manufacturers of medical products through the entire product life cycle, providing services as needed from initial concept through product approval to postmarket needs.
Source: MED Institute