The MedAccred program is making a big splash in the medical device industry. Learn what MedAccred accreditation is and how it may impact your company.
The medical device industry is going through substantial changes, with ISO 13485:2016, EU MDR, and MDSAP all taking center stage. If that weren’t enough, now we are seeing MedAccred gaining a tremendous amount of traction throughout the industry. MedAccred is an industry-managed supplier quality accreditation program focused on critical manufacturing processes, with objectives of enhancing patient safety, improving product quality, and assuring compliance with applicable requirements. It was created as a direct result of growing supplier quality issues, including frequent purchasing control violations noted in FDA 483 observations, several enforcement actions focused on purchasing controls, and an increase in the volume of recalls.
The MedAccred program is administered by the Performance Review Institute (“PRI”), a non-profit organization. With more and more medical device companies requiring their suppliers to receive MedAccred accreditation, the medical device industry is taking notice. As Connie Conboy, Director of MedAccred (PRI), recently explained, “MedAccred will be a game changer for the industry. The companies that really understand how [accreditation] is going to impact them are trying to roll it out as quickly as they can.” Here are 5 key points to understand regarding MedAccred:
MedAccred is a relatively new phenomenon, with plans to develop the program first originating in late 2012. However, despite its recent creation, it has quickly gained the attention of medical device leaders and has become one of the most critical issues facing organizations in our industry. More and more suppliers are seeking accreditation, not only as a result of a specific requirement from their customers to do so, but many are doing so proactively to take advantage of the many benefits that come with achieving accreditation. As many as 300 MedAccred audits are expected to be performed next year, and that number will continue to skyrocket. If you have not yet taken a hard look at the MedAccred requirements, the time is now.