Medical prime contractors are demanding that environmental conditions are controlled, processes validated, and the risk of foreign object debris (FOD) reduced. Performance Review Institute (PRI) states that 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 accreditation 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,” said Joe Pinto, executive vice President and chief operating officer at the Performance Review Institute. “Solar Atmospheres has worked hard to obtain this status and they should be justifiably proud of it.

“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 include: 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.