Medical Device Single Audit Program (MDSAP) Fundamentals and Audit Preparation
Level of Difficulty
Beginner (no knowledge at all of the topic).
Maintaining regulatory and quality compliance across multiple markets is challenging. In addition to meeting stringent regulatory requirements, manufacturers must also submit to regular quality system audits. When operating in multiple markets, this often means a busy audit schedule that can distract from daily operations.
Auditors must also duplicate efforts when evaluating systems that have already been approved by another regulatory body with similar requirements. The Medical Device Single Audit Program (MDSAP) aims to make it easier for manufacturers to comply with harmonized global quality management system (QMS) standards and to reduce the resource burden on the industry as a whole. MDSAP allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit.
In this course participants learn how to prepare fro a MDSAP audit.