For medical device manufacturing, quality is crucial. To ensure quality in production, audits of the manufacturing facilities by a government health organization are standard. The audits and inspections are not, however, standard between countries. The Medical Device Single Audit Program (MDSAP) is looking to change that.
MDSAP is an audit program designed from the International Medical Device Regulators Forum (IMDRF), an organization dedicated to harmonizing global regulations on medical devices. Specifically, the program was designed by IMDRF representatives from Australian, Brazilian, Canadian, Japanese and United States health organizations to satisfy the regulatory requirements of their five markets with a single audit. The program standardizes regulatory practices and procedures to promote consistency and transparency.