MDSAP Internal Quality Auditor Training Course

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The Medical Device Single Audit Programme (MDSAP) is a significant step towards harmonising medical device regulation across multiple global markets. This highly interactive training course provides a clear understanding of MDSAP requirements, demonstrates how they align with ISO 13485:2016 and US QMSR 21 CFR Part 820 and equips attendees with the auditing skills necessary to perform and MDSAP internal audit.

This two-day course, delivered by expert tutors combines practical auditing exercises with detailed guidance. The trainee auditors receive detailed feedback from both the tutor and their peers giving them the clarity and skills required to confidently undertake MDSAP audits once they return to the workplace.

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.

This practical two-day course develops both understanding and capability in internal auditing under the MDSAP framework. Topics include:

Introduction to MDSAP and its global scope
Regional regulatory requirements: Australia, Brazil, Canada, Japan, USA
Relationship of MDSAP to ISO 13485:2016 and US QMSR
Internal audit purpose, process and preparation
Selecting audit teams and effective auditor behaviours
Tools and techniques available to auditors
Internal quality audit procedure review
Practical audit exercises (case study or in-company audit)
Evaluating evidence and reporting audit results

On Day 2, learners participate in a practical internal audit exercise, which may take the form of a live in-company audit or a structured case study (for Public courses), providing valuable experience in preparing for, conducting and reporting on an MDSAP internal audit.

Content can be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting.

This programme is designed for individuals responsible for conducting internal audits against MDSAP requirements.

The training is particularly beneficial for:

Quality Managers, Quality Engineers and Supervisors new to MDSAP
Departmental Managers and staff with audit responsibilities
Personnel responsible for supplier or external audits
Staff involved in designing or implementing quality systems

A basic knowledge of ISO 13485:2016 is helpful but not essential. No prior internal auditing experience is required.  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 purpose and importance of internal auditing in a Quality Management System.
Identify and interpret the MDSAP requirements of Australia, Brazil, Canada, Japan and the USA.
Map regulatory requirements to ISO 13485:2016 and US QMSR 21 CFR Part 820.
Plan and prepare for an internal audit against MDSAP requirements.
Apply effective audit techniques, including evidence collection, analysis and reporting.
Demonstrate professional auditor behaviours, such as active listening and constructive communication.
Evaluate audit findings and prepare clear, structured reports.

These outcomes ensure that learners return with the practical skills and knowledge necessary to perform effective internal audits against global MDSAP requirements.

Our tutors are industry specialists with extensive experience in medical device regulation, auditing and quality systems. 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.

Both provide learners with expert guidance, practical knowledge and ongoing support throughout the training.

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 10-12 participants to support personalized learning and individual support.

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

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

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Snapshot

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Course Code

LS004

Duration

2 training days

Public Price

Classroom: £800
Virtual Training: £710

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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