Medical Devices Single Audit Program (MDSAP) Training

  • Overview
  • On-Site Training
  • Virtual Training
  • Who Should Attend?
  • Trainer Profile

NSF’s on-site and virtual Medical Device Single Audit Program (MDSAP) training courses provide in-depth knowledge and allow you to prepare your company for the MDSAP audit and the upcoming regulatory changes.

The MDSAP audit process was designed and developed to ensure a single audit provides efficient yet thorough coverage of multiple medical devices auditing requirements. Some of these requirements include:

  • ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes
  • RDC ANVISA 16/2013 – Brazilian Good Manufacturing Practices
  • MHLW Ministerial Ordinance No. 169 – Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents
  • 21 CFR 820 – U.S. Quality Management System Regulation

MDSAP-recognized Auditing Organizations (AOs) can 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. The participants include Australia’s Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada (HC), Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW and PMDA) and the United States Food and Drug Administration (FDA). Acting as official observers are the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU).

On-Site Training

NSF’s one-day MDSAP training course helps you better understand the requirements of this medical devices auditing program. You will learn to:

  • Understand the MDSAP and how Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s PMDA and the U.S. FDA will implement the program moving from the pilot to the operational phase
  • Understand the new regulatory QMS audit findings/nonconformance 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 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

This two-hour 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. At the end of the course, there is a 20-question competency assessment. If successfully completed, you will be provided with a Certificate of Successful Completion to add to your company’s training files.

Learning Outcomes

After completing this MDSAP training 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

Visit our eLearning online portal to see this course. Log in, sign-up and start learning!

For large groups, we can offer a live 30-minute Q&A with Kim Trautman answering your MDSAP questions in real time.

Who Should Attend?

This course is vital for any medical device quality professional (including quality directors, managers, engineers and auditors) responsible for implementing a quality management system in accordance with ISO 13485:2016 and planning to undergo an MDSAP audit.

Trainer Profile

NSF's medical devices training 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 Medical Device Single Audit Program training course:

Upcoming Courses & Webinars

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