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.
Why You 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 requires 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.
- Overview of the MDSAP Program
- Benefits of the MDSAP Process
- Jurisdictions participating
- Review the MDSAP Model
- The audit sequence
- Preparing for the MDSAP
- Regulatory Affairs Departments
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Internal Auditing