Medical device manufacturers face an increasingly competitive business environment. A strategic advantage comes from the Performance Review Institute (PRI) that administers an accreditation program to help American manufacturers increase competitiveness, decrease costs and improve patient safety. The Michigan Manufacturing Technology Center (The Center) has the expertise to guide you through this accreditation process to grow your business.

What is MedAccred® Accreditation?

MedAccred® is an industry-managed supply chain accreditation program created by PRI that aims to reduce risk to patient safety and assure quality products made in compliance with requirements for critical processes used in the production of medical devices. Such critical processes include: 

  • Cable & Wire Harnesssteth-medaccred.jpg
  • Heat Treating
  • Plastics Extrusion
  • Plastics Injection Molding
  • Printed Circuit Board Assembly    
  • Sterilization    
  • Welding
  • Printed Boards    

By achieving this MedAccred® accreditation, medical device manufacturers can gain greater operational efficiency, improve product quality and — importantly — maintain a competitive advantage over manufacturers who do not have this accreditation.

HELP is available EVERY STEP OF THE WAY

To support medical device manufacturers throughout the accreditation process, The Center is a select member of the Medical Manufacturers MedAccred® Accreditation PathwaySM (MedMMAP). Created in collaboration with PRI, MedMMAP connects manufacturers with industry-approved and trained experts to help prepare them for the accreditation process. 

Since this detailed, technical accreditation is unlike typical Quality Systems audits, it is essential for industry experts to help with expediting the process and ensuring requirements are closely followed. MedMMAP program experts from The Center support manufacturers through multiple stages of preparation before PRI completes the official accreditation audit. These steps include:

  1. Critical Process Assessment conducted by an industry expert from The Center.
  2. Gap Closure facilitated by our experts, which uses findings from the initial assessment to determine which areas need improvement. 
  3. Accreditation Audit performed by PRI auditors. 
  4. Closing Audit Findings, with our experts returning to assist with closing any remaining gaps in compliance. 
  5. Final Review and Official Accreditation Certification awarded by PRI.

BOOST YOUR COMPETITIVE EDGE

The time is now. With OEMs preferring or requiring a supplier to hold MedAccred® accreditation for new business, it is imperative that U.S. manufacturers with critical processes gain accreditation, or risk being shut out by global competitors.

To learn more about MedAccred® accreditation, Ask Our Experts.

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