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.
What You Need to Know Regarding MedAccred Accreditation
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:
- To date, MedAccred focuses on 8 critical processes: cable and wire harness, heat treating, plastics extrusion, plastics injection molding, printed board, printed circuit board assemblies, sterilization, and welding. The number of critical processes is expected to increase with further input from industry experts and the FDA.
- Receiving MedAccred accreditation offers several crucial benefits to suppliers such as clearly demonstrating to current and prospective customers an unwavering commitment to the highest quality standards, offering a mechanism for suppliers to clearly differentiate themselves from the competition in order to both maintain and add business, and providing for a more cost-effective and efficient audit process which will save time and money by eliminating the need for multiple and redundant audits performed by various parties.
- There are also sizable advantages for medical device companies, or OEMs, to require MedAccred accreditation from their suppliers, including more consistent audit criteria based on industry consensus, improved visibility and confidence in supplier quality and reduced risk from under-performing suppliers, and enhanced insight into potential issues with critical processes.
- Suppliers should coordinate a MedAccred audit directly with PRI. PRI will schedule the audit with a qualified auditor, work with the supplier to close-out any audit issues noted, and issue a certificate to the supplier following successful completion of the audit.
- Before moving forward with a MedAccred audit, suppliers must first conduct a gap assessment to determine where their current processes fall short as compared to the MedAccred requirements, and then analyze what actions and resources are needed to close those gaps and/or prepare for the audit. Suppliers should also strongly consider conducting an internal audit or mock audit to identify potential areas of concern and provide an opportunity for remediation prior to the commencement of the MedAccred audit.
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.
