MDSAP Training – Medical Device Single Audit Program

USD $35.00

Course duration: Allow 2 to 3 hours to complete this course.

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An online MDSAP Training course to help you better understand the requirements of MDSAP – the Medical Device Single Audit Program.

MDSAP was launched by the IMDRF and its original participating members, including the US FDA, the Australian TGA, ANVISA in Brazil, Health Canada, and shortly afterwards, Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).

MDSAP – Medical Device Single Audit Program (Training & FAQs)

This online course will help you better understand MDSAP (Medical Device Single Audit Program) including the many guidelines you will need to familiarise yourself with, the MDSAP Audit Policy document, and the MDSAP non-conformity grading system.

Topics covered in this eLearning course include:

  • What’s required for participation in the MDSAP program?
  • What do the 3 levels of participation actually mean (Member, Official Observer, and Affiliate Member)?
  • Which jurisdictions/Regulatory Authorities accept MDSAP Audit reports?
  • What are the roles and responsibilities of Regulatory Authorities vs Auditing Organisations (AOs)?
  • What does the scope of an MDSAP Audit contain?
  • How long does an MDSAP Audit take (MDSAP audit duration)?
  • What is a Surveillance Audit in the MDSAP?
  • How often do Surveillance Audits need to occur in the MDSAP (Medical Device Single Audit Program)?
  • What’s the audit process and the nonconformity grading system for MDSAP participants like, compared to ISO 13485:2016 QMS audits?

Click here for other Medical Device Regulatory Compliance Training Courses.

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MDSAP Training, ISO 13485 and Other Regulatory Compliance Courses

This product is a Certificate Course covering MDSAP requirements and Regulatory Compliance expectations. It will assist Inspectors/Regulatory Authority Representatives, manufacturers, and distributors participating in the Medical Device Single Audit Program (MDSAP).

MDSAP training - mdsap-audit-duration-howlong

This course provides learners with a helpful resource pertaining to MDSAP audits for medical device manufacturers, with examples and resources from:

  • IMDRF – International Medical Device Regulatory Forum 
  • US FDA MDSAP pages
  • Australian TGA MDSAP pages
  • Health Canada
  • ANVISA Brazil
  • Japan

It includes helpful MDSAP guidance information for Manufacturers, Management, Regulatory Authority Personnel, Medical Device Industry Quality Personnel, and Auditing Organisations (AOs) who are seeking recognition/approval by IMDRF to conduct MDSAP audits.

MDSAP Guidance for Medical Device Manufacturers & Regulatory Authorities

About this interactive online course overviewing MDSAP (Medical Device Single Audit Program)

This is one of our many Medical Device and GMP education topics available in an eLearning format (accessible 24/7) after purchase.


Who should take this Medical Device Regulatory Compliance & MDSAP Auditing Training Course?

Medical Device Manufacturers participating in MDSAP

  • This course is suitable for a wide range of personnel and management roles at the manufacturer level.
  • It is suitable for manufacturing companies currently participating in MDSAP and for companies investigating MDSAP participation requirements.
  • This MDSAP training presentation includes IMDFR MDSAP information, FDA MDSAP guidance, MDSAP participation requirements, MDSAP membership application links, and more.

Regulatory Authorities of Countries Participating in MDSAP

The course is also suitable for Regulatory Authorities and Auditing Organisations (AOs) and other auditors working in the Medical Device sector and/or medical device export industry.

While completing this course is helpful to understand MDSAP participation requirements and expectations, learners still need to download and read all applicable regulations and standards, e.g.:

  • ISO 13485:2016 – Quality Management Systems for Medical Devices
  • ISO 14971:2019 – Medical Device Risk Management
  • MDSAP Audit Policy
  • Auditing Organisation Recognition and Approval Process Policies and Forms
  • Other relevant publications/guidance documents

Explore the online GMP special training bundles (combined training packages).

Purchasing several courses at one time helps you save on your training budget. Alternatively, you can purchase a single course, or just a few of the courses you need, to engage in ‘just in time’ learning.


Note: All course prices are in US dollars ($35 USD is equivalent to approximately $55 AUD).

Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

About this Medical Device Industry Regulatory Compliance/MDSAP Audits training course


Review other top-ranked Medical Device Regulations/MDR, ISO compliance training, and best-practice cGMP training courses, all online.

How to complete this course.
  • Add the online MDSAP Training course to your basket
  • Complete your purchase online using a credit card
  • Remember, course fees are listed in US Dollars
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One user/per licence purchase (12 months’ access)
  • This MDSAP training course is available fully online (24/7 access).
  • One learner (user) per licence.
  • Course completion provides learners with a foundational understanding of the key elements of the MDSAP/Medical Device Single Audit program and auditing requirements for AOs, including reporting time frames and a list of the tasks required for an MDSAP Audit

Do you need to train your personnel to comply with Regulatory Compliance requirements?