| |  | As the EU Medical Device Regulation (MDR) transition deadline for legacy devices has passed, medical device manufacturers must explore alternative avenues to sell their devices abroad. Leveraging schemes such as MDSAP (Medical Device Single Audit Program), Swissmedic, and UKCA, in conjunction with ISO 13485, can facilitate market access in various regions. Notably, the five MDSAP jurisdictions include 751 million people as compared to the European Union with 448 million. MDSAP opens the door to those markets with a single yearly audit built upon a quality model with great familiarity, ISO 13485. Cost savings can be significant and alternative regulatory approaches multiply the quality management and regulatory outcomes by giving medtech firms multiple marketing pathways with singular effort. Additionally, MDSAP can significantly enhance a manufacturer's preparedness for the new Quality Management System Regulation (QMSR) with the FDA through streamlined compliance within a harmonized approach and comprehensive audit coverage.
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