In the highly regulated world of medical device manufacturing, ensuring the highest standards of quality and compliance is non-negotiable. Two key programs that play a vital role in this industry are the ISO 13485 and the Medical Device Single Audit Program (MDSAP). While they both aim to ensure that medical devices are safe and effective, they do so in different ways. In this blog, we’ll explore the fundamental differences between ISO 13485 and MDSAP, helping you understand their unique features and how they can benefit your organization.