MDSAP – Medical Device Single Audit Program Reduced audit effort for medical device companies
As a result, additional audits by further authorities which are part of IMDRF will only be necessary in exceptional cases. For medical device manufacturers, this means fewer audits, less audit preparation effort required, and reduced staff expenses. But MDSAP also brings new challenges: not only requirements placed on QMS by ISO 13485, but also compliance with the requirements of multiple MDSAP authorities. Standards for combination products are especially strict. The timeline for processing non-conformities (NC) is also tight. With an NC degree of 4 or higher, medical device manufacturers have 15 days to set up and hand over a migration plan to the corresponding AO. This plan has to be implemented and proof provided for all measures that were carried out within 30 days after the audit ended.
Do you need an expert on your side? With experience in over 550 compliance projects, we would be happy to provide you with consultation and support in optimizing your QMS in line with MDSAP requirements. Get in touch with us…
… or subscribe to our newsletter. In our summer issue of UPDATE (no. 2 | 2018) we will provide a detailed report on challenges and opportunities presented by MDSAP, and give some practical insight into current projects.
Global Head of Business Development