MedAccred Expands Access to Small and Medium Sized Medtech OEMs

MedAccred has expanded its accreditation program to small and medium sized medical device OEMs. The new associate subscriber level allows companies with less than $250 million in annual revenue to access audit details of the program at a substantially reduced subscription rate. Suppliers to the medical device industry also have access to the program by becoming a contract manufacturer subscriber.

A not-for-profit supply chain oversight program, MedAccred claims to be the only industry-managed program of its kind for key critical manufacturing processes in the medical device industry. The audit requirements that must be met to achieve accreditation are set forth by MedAccred subscribing members, which include Bausch Health, Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics, and Stryker.

The new subscriber options bring the following benefits to a much larger segment of the medical device industry, according to MedAccred:

Related:MedAccred’s Singular Pathway to Medtech Quality and Regulatory Compliance

The MedAccred program was established in 2012 and is administered by Performance Review Institute (PRI), which also supports the longstanding Nadcap accreditation program for the aerospace industry. Since its founding, MedAccred has developed audit systems for cable and wire harness production, heat treatments, plastics, printed circuit board assemblies, sterilization, and welding. 

Audit criteria for injection molding were first released in June 2016. Injection molders that have earned accreditation since then include BMP Medical, Hoffer Plastics, PTA Plastics, Elcam Medical (Israel), Intertech Plastics, Jabil (Puerto Rico), and most recently Technimark in Ireland.