MDSAP training

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Introduction to MDSAP

The Medical Device Single Audit Plan is beyond the pilot program phase and is starting up to replace the normal audit structure. Countries which embrace MDSAP are Australia, Brazil, Canada, Japan and the United States of America. Canada has already announced that as of January 1st, 2019 only audit results according to MDSAP are accepted for regulatory compliance and submissions. It can be expected that other associated Regulatory Authorities will do the same in due time. Audit Organisations also start preparing and implementing the Medical Device Single Audit Plan. So you should do the same.

During the course, you will obtain the knowledge to understand MDSAP and the possible impact on your organization. What are the fundamentals of MDSAP, how are audits performed and what do you need to do to prepare your own organization. 






Program overview

Duration: 1 day

Program overview:

What is MDSAP?

How does MSDAP work?

What are the MDSAP requirements

Does your organization fulfil the requirements?

What do I need to do to facilitate a MDSAP audit?


Questions & Answers

Learning objectives

  • MDSAP fundamentals
  • Principles and approach of the MDSAP program
  • Process structure and audit tasks
  • MDSAP documentation
  • MDSAP requirement structure and contents
  • Approach of an auditing organization
  • Understand the non-conformity grading
  • Analyze and define the impact of the MDSAP program on your own organization/certification program

Who should attend?

This training is meant for management, QA and RA managers, internal audit coordinators, internal auditors and others involved in internal and external audits. 

A specific entry level is not required. The requirements are based on ISO 13485, so a basic understanding and knowledge of the standard are beneficial.


We offer on-location and train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.