Medical Device Single Audit Program (MDSAP) Training

  • Overview
  • On-site Training
  • Virtual Training
  • 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)

NSF’s on-site and virtual training courses provide the knowledge your company needs to prepare for MDSAP audits and the coming regulatory changes.

On-site Training

NSF International’s in-person training courses provide the knowledge your company needs to prepare for MDSAP audits and the coming regulatory changes. Our highly interactive course features real scenarios and exercises to help you apply the learning in an intimate class setting.

Sample Agenda
This intense course will cover:

  • 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

Virtual Training

MDSAP and Regulatory Transitions – The Basics: Virtual Training With Live Expert Q&A

In addition to our on-site interactive MDSAP classroom training, NSF offers a two-hour virtual MDSAP training course. This web-based course offers your organization the flexibility and efficiency of a virtual classroom environment to learn the basics to prepare for MDSAP. It also helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from our in-house expert, Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Trautman also authored and led the implementation of the current U.S. FDA Quality System regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485.

Our remote overview training provides an informative 90-minute presentation, followed immediately by a live question/answer session with Trautman. This allows simultaneous education of your employees all over the world, and they’ll participate in the live Q&A session together as a group.

Learning Outcomes
After completing this course, you will:

  • Understand the new regulatory audit findings/nonconformance grading system and know what grades trigger regulatory follow-up within MDSAP
  • Recognize the value of the MDSAP audit model
  • Be familiar with the premise of the MDSAP audit time calculations
  • Be familiar with the basic information to be included in the MDSAP audit report
  • Comprehend the MDSAP timeline and other upcoming regulatory changes

What You Get

  • A 90-minute video presentation from MDSAP recognized expert, Kim Trautman
  • 30 minutes of live Q&A with Kim Trautman – answers to all your MDSAP questions in real-time
  • Live links to MDSAP resource documents to view during the presentation
  • Competency assessment certification to add to your company’s training files (two hours + exam completion)

Professional Fees

  • $100 per person for 25 – 50 participants
  • $75 per person for 51 – 99 participants
  • $50 per person for groups of 100 attendees or more

For more information, contact us at nsfmdtraining@nsf.org or +1 202 822 1850.

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:

Upcoming Courses & Webinars

In Medical Device Single Audit Program (MDSAP) Training
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