Results for tag: "Medical Device Single Audit Program"

The Medical Device Single Audit Program (MDSAP) is a quality management system that enables medical device manufacturers to be audited once to meet the requirements of multiple regulatory authorities. It is a voluntary program that allows manufacturers to demonstrate compliance with applicable regulatory requirements in multiple jurisdictions. The program is designed to streamline the process of obtaining regulatory approval for medical devices, reducing the time and cost associated with multiple audits. MDSAP is administered by the International Medical Device Regulators Forum (IMDRF), a global organization of medical device regulators from around the world. The program is open to medical device manufacturers in all countries, and is designed to facilitate the global trade of medical devices. Some companies in the MDSAP market include Abbott, Becton Dickinson, Johnson & Johnson, Medtronic, Philips, Siemens Healthineers, and Stryker. Show Less Read more