The Medical Device Single Audit Programme Training Course

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The Medical Device Single Audit Programme (MDSAP) represents a major step towards the harmonisation of international medical device regulations. This highly interactive two-day training course provides a detailed understanding of the requirements from Brazil, Australia, Canada and Japan and how they align with ISO 13485, the EU MDR and the US Quality Management System Regulation (QMSR). The course is delivered by highly experienced tutors and provides an in-depth examination of the MDSAP audit process, including comprehensive guidance on effective preparation.

We can tailor the training to meet your specific training needs and incorporate examples from your processes and procedures into the training programme as required.

The programme introduces the principles of MDSAP and provides learners with the tools to prepare for and succeed, in the audit process.

Day 1

Introduction to MDSAP
Role of Auditing Organisations (AOs)
MDSAP Audit Process including:
Application process
Three-Step Audit Approval System
Audit Companion Document
Non-conformance Rating System
Audit approval and re-certification timelines
Advantages and disadvantages of MDSAP adoption
Regulatory requirements for registration and labelling in Brazil, Australia, Canada and Japan compared to EU and US regulations

Day 2

Quality Management System requirements by region:
Brazil (ANVISA RDC 16/2013)
Australia (Therapeutic Goods Regulations SR 2002 No. 236)
Canada (CMDR SOR/98/28)
Japan (PMD Act 2014)
How these relate to ISO 13485 and US QMSR 21 CFR Part 820
Participation in mock audit scenarios
Practical guidance on preparing for an MDSAP audit

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises. If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting.

This course is designed for professionals working in quality, compliance and auditing roles in the medical device sector.

The training is particularly beneficial for:

Quality Managers and Quality Engineers
Staff responsible for designing and implementing Quality Systems
Internal Auditors
Personnel responsible for supplier or external audits
Departmental Managers and supervisory staff

A good standard of written and spoken English is important to engage effectively with this programme.

On successful completion of this course, learners will be able to:

Explain the core principles of the MDSAP framework.
Compare regulatory requirements across Brazil, Australia, Canada, Japan, the EU and the US.
Identify Quality Management System requirements critical for MDSAP compliance.
Implement key steps to prepare for an MDSAP audit.
Analyse audit findings and integrate them into a compliance programme.
Develop an approach for maintaining ongoing compliance across MDSAP participant countries.

These outcomes ensure that learners return with the practical skills and knowledge necessary to prepare effectively for audits and maintain global regulatory compliance.

This programme is led by highly experienced tutors with deep expertise in medical device regulation and auditing. Each Tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support.

Learners benefit from the tutors’ practical insights and ongoing support throughout the course.

Gerry Burke

Gerry is a self-motivated medical industry professional with kn...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs

Pre-training consultation for in-company courses to tailor content to organisational needs
Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation.
Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
Live training is available virtually or delivered onsite to suit the needs of the team
Real-time support from expert tutors

Class sizes are generally limited to 12-15 participants to support personalised learning and individual support.

Learners who complete this course often continue to deepen their skills in:

MDSAP Internal Quality Auditor
ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)
Medical Device Risk Management and ISO 14971:2019
Internal Quality Auditing for Manufacturers of Medical Devices
Technical Writing Skills

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Snapshot

Online Learning FAQ >

Course Code

LS005

Duration

2 training days

Delivery Mode

Available for In-House and delivered through virtual classroom training.

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News & Updates

Why is everyone talking about MDSAP and Health Canada? Read our second blog

As we have seen in the first of our blogs submitted by John Lafferty, MDSAP is the Medical Device Single Audit Programme which consists of a single Quality Man...