The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to consolidate compliance audits from five separate markets or Regulatory Authorities (RAs) with a single audit. Currently, Australia, Brazil, Canada, Japan, and the United States are participating in the program – with Health Canada requiring MDSAP certification.
Our course provides a solid understanding of the MDSAP program, what to expect during an MDSAP audit, and the key regulatory requirements for MDSAP-participating countries. Through interactive workshops and exercises, participants apply the MDSAP process-based audit approach– including the scoring system that Auditing Organizations (AOs) will use during certification audits. Participants in this class gain additional insight from case studies that share best practices and include practical examples gathered from our customers who have successfully passed their MDSAP certification audits.
Which MDSAP training is right for you?
Is your organization preparing for MDSAP (or thinking about MDSAP)?
Then this class is right for you.
Do you need to learn how to perform internal audits to MDSAP requirements?
Then take our Internal Auditing to MDSAP class. Designed for experienced auditors, participants learn how to apply MDSAP's process-based audit approach and align your current internal audit program to the MDSAP requirements. You will also take a detailed look at country-specific requirements for the five MDSAP participant markets.