MedMMAP Newsletter 1

Medical Manufacturers MedAccred ® Accreditation Pathway

March 2018

What is MedAccred ® ? An industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. MedAccred is ad- ministered by Performance Review Institute (PRI). Visit p-r-i.org/medaccred for more information. U.S. Medical Device Manufacturer Challenges OEMs are beginning to talk of requiring MedAccred accreditation as a requirement for new business, and foreign based facilities are aggressively pursuing accredita- tion as part of their strategy to capture market share in the US. A significant loss of domestic share in the markets is forecast without a substantial change in US supplier competitiveness. Domestic supply chains offer significant ad- vantages in terms of lead time, innovation and on time performance. MedAccred accreditation enables those companies to also provide a preeminent position re- garding quality of product supplied, a major factor contributing to total cost of own- ership and supplier selection .

“Eventually, the direction is to be making business decisions based on MedAccred. Awarding business based on ac- creditation [to MedAc- cred] is the end goal.”

- Scott Goolsbey Stryker Corp

MedMMAP — An MEP National Network Program Q: What is MEP? A: MEP is a public-private partnership with Centers in all 50 states dedicated to enabling U.S. manufacturers to identify opportunities that will accelerate and strengthen growth and competitiveness in the global marketplace. Q: What is the mission of MedMMAP? A: To provide manufacturers with effective audit preparation for MedAccred accreditation, to increase competitiveness of U.S. medical device and medical instrument manufacturers, decrease industry costs, and improve patient safety.

In This Issue  What is MedAccred?  U.S. Medical Device Manufacturer Chal- langes  MEP and MedMMAP  Impetus for Action  Reducing Costs

Heat Treating is one area of critical process accreditation (Photo: Solar Atmospheres)

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