Medical Device Single Audit Program (MDSAP) Training

  • Overview
  • Sample Agenda
  • Learning Outcomes
  • Who Should Attend?
  • Trainer Profile

The Medical Device Single Audit Program (MDSAP) audit process was designed and developed to ensure a single audit will provide efficient yet thorough coverage of multiple requirements including Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), the U.S. Quality System Regulation (21 CFR Part 820) and other specific requirements of medical device regulatory authorities participating in the MDSAP.

MDSAP-recognized Auditing Organizations can now conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the program. Participating authorities include:

  • Australia: Therapeutic Goods Administration (TGA)
  • Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
  • Canada: Health Canada (HC)
  • Japan: Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW and PMDA)
  • United States: Food and Drug Administration (FDA)
  • Official Observers: The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU)

This course provides the knowledge your company needs to prepare for MDSAP audits and the coming regulatory changes.

Sample Agenda

The agenda for our MDSAP training class might look like this:

  • Welcome and introductions
  • MDSAP overview
  • GHTF N19 nonconformance grading overview
  • ISO clause and NC grading exercise
  • MDSAP requirements and documents
  • MDSAP audit model and companion guidance
  • MDSAP audit time calculation
  • MDSAP audit reports
  • ISO 13485:2016 and MDSAP transitions
  • Questions and answers

Learning Outcomes

After completing this class, you will be able to:

  • Understand the MDSAP and how Australia’s TGA, Brazil’s ANVISA, Canada’s HC, Japan’s PMDA and the United States’ FDA will implement the program moving from the pilot to the operational phase
  • Understand the new regulatory QMS audit findings/non-conformance grading system and what grades trigger regulatory follow-up
  • Explain how the European Commission, the WHO IVD Prequalification Program and other emerging regulators are participating in and utilizing parts of the MDSAP
  • Understand the new ISO 13485:2016 revision for regulatory and certification purposes
  • Comprehend the regulatory transitions for MDSAP and discuss strategies on how companies can optimize alignment

Who Should Attend?

This course is vital for any medical device quality professional, as well as quality directors, managers, engineers and auditors who implement their quality management system.

Trainer Profile

NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainer for this course:

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