For many companies, selling a product into one country’s market is challenging enough. There are specific regulations with which they must comply and be able to stand up to the country’s regulatory agency audit. Companies like these can hardly imagine meeting the requirements of multiple agencies in multiple nations to sell products more broadly.

Fortunately, a regulatory avenue provides a pathway to do just that. The Medical Device Single Audit Program (MDSAP) offers a way for companies to meet the regulations of multiple nations while doing so via a single inspection conducted by a recognized auditing organization. The program opens the door to market into certain countries that participate or recognize in it. Of course, regulatory review of the product is still required.

To further explain the details of MDSAP, why it may be attractive to medical device OEMs, and how contract manufacturers can benefit, Dawn Tibodeau, Global Regulatory Affairs Principal – MDSAP at TÜV SÜD America Inc., participated in the following Q&A. She responds to several questions on these topics while also offering more insights on the specifics of the program.

Sean Fenske: What is MDSAP and why is it relevant to medical device manufacturers?

Dawn Tibodeau: MDSAP is a single audit based on ISO 13485 and country-specific regulations, which is conducted by authorized or recognized auditing organizations and…