Medical Device Single Audit Program – An Overview
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
The Medical Device Single Audit Program (MDSAP) is a process that allows a single audit to occur of a medical device manufacturer's Quality Management System to determine if it satisfies the requirements of multiple regulatory jurisdictions.
The MDSAP Audit is a one-time audit for compliance with the regulatory requirements of five current participant countries: Australia, Brazil, Canada, Japan, and the United States.
MDSAP Audits are performed by approved Auditing Organizations (AO), authorized by the regulatory bodies of the participant countries.
This webinar will overview the critical elements of the process and discuss the current status of MDSAP across all participant members.
- overview of the MDSAP Program
- Benefits of the MDSAP Process
- Jurisdictions participating
- Review the MDSAP Model
- The audit sequence
- Preparing for the MDSAP
Course Level - Beginner/Intermediate
Who Should Attend
- All functions involved with the maintenance
- And the application of one or more elements of a medical device manufacturers Quality Management System
Why Should Attend
Global Medical Device Regulations are complex and are in a constant state of revision necessitated by the ever-increasing sophistication of medical device designs and applications.
The marketplace and individual patient need require an expedited speed-to-market approach to the manufacture of medical devices that provide life-saving therapies across a broad spectrum of diseases and physical requirements.
The MDSAP is one of the many approaches to speeding this process. Understanding the program in general, the audit process and the nonconformity grading matrix is essential for a company to complete an audit successfully. This webinar will provide that level of understanding.