First MedAccred Critical Process Accreditation Awarded

MedAccred News

View all the latest news and archives for MedAccred

First MedAccred Critical Process Accreditation Awarded

19 May 2015

Solar Atmospheres, Inc. of Souderton, Pennsylvania in the U.S. has become the first company to receive MedAccred critical process accreditation.  Medical device original equipment manufacturers (OEMs) are demanding that environmental conditions are controlled, processes validated, and the risk of foreign object debris reduced.

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. Solar Atmospheres 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 Solar Atmospheres 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 Solar Atmospheres, 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 certificate.”

Benefits of MedAccred:

  • Provides consistent/standardized critical process accreditation accepted by 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
  • Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.

Mike Moyer, Director of Sales at Solar Atmospheres, Inc. states, “Many companies only enter these programs when their customers mandate compliance.  At Solar Atmospheres we embrace these programs as opportunities. It is a good thing when industry original equipment manufacturers and final device makers recognize the benefits that accrue when suppliers become involved in the global management of activities surrounding their special process. After all, who knows a special process better than the companies that perform it every day?  These programs inevitably bring the OEMs and suppliers together at the same table where pertinent discussions lead to achieving the following goals: first, improvements in the substance and flow-down of the requirements from the OEMs, second, improvements in the performance of the supplier base, and third, improved products to doctors and patients resulting in better quality medical care with fewer complications.”

For additional information, please contact PRI at