Beginner (No knowledge at all of the topic).
MDSAP stands for the Medical Device Single Audit Program. MDSAP is a regulatory program that allows medical device manufacturers to undergo a single audit that satisfies the quality management system requirements of multiple regulatory authorities participating in the program. The main goal of MDSAP is to streamline regulatory processes and improve the efficiency of audits for medical device manufacturers operating in multiple markets.
This course provides a foundational understanding of the MDSAP. Participants explore the program’s origins, certification process, terminology, and application across global markets. Key components such as MDSAP requirements, audit procedures, and non-conformity grading are covered. Participants gain insight into the relationship between ISO 13485:2016 and MDSAP, as well as the regulatory landscape of medical device markets. By course end, participants are equipped to navigate MDSAP effectively and ensure compliance within their organizations.
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