MedAccred

MedAccred is an accreditation program for critical process manufacturing operations in the production of medical devices MedAccred is an industry managed program with the medical device industry having responsibility for all decisions regarding program operations, development, and the decision to award accreditations. The MedAccred program is administered on behalf of the medical device industry by the Performance Review Institute (PRI), a not-for-profit affiliate of SAE International. Participants in the MedAccred program consist of medical device OEMs, contract manufacturers and suppliers who work together to develop industry-wide audit criteria and provide accreditation of critical manufacturing process suppliers to improve product quality.

MedAccred was created following a medical device industry roundtable in held in Chicago, IL in December 2012. Companies present at the roundtable included Abbot Laboratories, Baxter International, Beckman Coulter, Boston Scientific, Brunk Industries, DePuy Synthes, GE Healthcare, Medtronic, Paragon Medical, Philips, Stryker, Symmetry Medical, Terumo Cardiovascular Systems and Zimmer Biomet. Proof of concept audits based on the Nadcap program audit criteria were conducted in 2013. Briefings on the MedAccred program were held with the FDA Center for Devices and Radiological Health’s (CDRH) Office of Compliance and the FDA’s Office of Global Operations within the Office of the Commissioner.The initial subscribing companies were Johnson & Johnson, Philips and Stryker.

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