Medical Device Single Audit Program (MDSAP)

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.

Areas Covered in the Session :

  • Overview of the MDSAP Program
  • Benefits of the MDSAP Process
  • Jurisdictions participating
  • Review the MDSAP Model
  • The audit sequence
  • Preparing for the MDSAP
Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Internal Auditing

MD2408

Charles Paul

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance