First MedAccred Sterilization Accreditation Awarded to Synergy Health

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First MedAccred Sterilization Accreditation Awarded to Synergy Health

01 March 2016

Synergy Health in Alajuela, Costa Rica has become the first company to receive MedAccred sterilization accreditation, on January 5, 2016.

This follows the successful development of the MedAccred Audit Criteria for Sterilization by the MedAccred Sterilization Task Group (AC8113, AC8113/1 and AC8113/2). The audit criteria include Radiation (Electron Beam and Gamma) and Ethylene Oxide.  The members of the Task Group come from companies including Johnson & Johnson, Philips, Stryker, Baxter Healthcare, Becton, Dickinson & Co., DSM Biotech, Synergy Health and Flex. The Sterilization audit criteria draw from Industry Standards as well as the most common customer specifications.

Wendy Gould, VP Regulatory Affairs & Quality at Synergy Health said “We look forward to making it easier for our customers to do business with us, leveraging the MedAccred program will reduce their costs and improve audit consistency”.

MedAccred is an industry managed supply chain oversight program that bolsters patient safety.  It does this through clarification of requirements and better identifying how they apply to critical processes used in the production of medical devices.

“Achieving MedAccred status is not easy: it is one of the ways in which the medical device manufacturing industry identifies those suppliers capable of providing superior critical process manufacturing to the Device industry. Synergy Health has worked hard to obtain this status and they should be justifiably proud of it,” said Joe Pinto, Executive Vice President and Chief Operating Officer at the Performance Review Institute. “PRI is proud to support continual improvement in the medical device manufacturing industry by helping companies such as Synergy Health be successful and we look forward to continuing to assist the industry moving forward. I would like to add my personal congratulations to everyone at Synergy Health, as the company has been actively involved in the MedAccred program for some time now, and volunteered to pioneer this process. Their positivity and diligence has paid off and I am delighted to award them the first ever MedAccred sterilization certificate.”

Sterilization is just one area for MedAccred: there is also activity in other critical process areas such as Cable and Wire Harness, Heat Treating, Plastics, Printed Circuit Board Assemblies, and Welding.

Benefits of MedAccred:

  • Provides consistent/standardized critical process accreditation accepted by leaders in the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
  • Conducts in-depth critical process audits that are compliant and consistent to accepted industry/technical standards and conducted by Subject Matter Experts
  • Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.)
  • Improves flow down of OEM requirements to sub-tier suppliers