Solar Atmospheres Inc. of Souderton, Pa., received MedAccred critical process reaccreditation. The company also successfully expanded its scope of accreditation to include hardness testing and metallography and microindentation hardness.
MedAccred is an industry-managed critical process supply-chain oversight program developed by leading medical-device companies to improve device quality and enhance patient safety. The effort to establish MedAccred began in 2010 when the Performance Review Institute (PRI) was asked to consider the development of a Nadcap-style special process supplier accreditation program for the medical device industry. By 2014, several critical process Task Groups were operating on a formal basis, program documents were drafted and approved by the executives of the participating companies, and audit criteria had been published in several critical process areas.
The first MedAccred critical process accreditation was issued to Solar Atmospheres Inc. in early 2015 for Heat Treating.
Today’s functioning critical process Task Groups include Cable & Wire Harnesses, Heat Treating, Plastics Injection Molding, Printed Circuit Board Assemblies, Sterilization and Welding. The industry-managed groups develop audit criteria, conduct audits and award MedAccred Critical Process Accreditations to leading suppliers at all tiers in the medical-device supply chain.
Future MedAccred Task Groups under consideration for development include Material Testing Laboratories, Assemblies, PCBs, Batteries, Chemical Processing, NDT, Cleaning, Coating, Optics and Packaging.
Active OEM and contract manufacturer participants include: Johnson & Johnson, Philips, Stryker, GE Healthcare, Medtronic, NYPRO Jabil and Steris.