MDSAP: The Medical Device Single Audit Programme

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 knowledge and experience of remediation in the highly regulated medical device, pharmaceutical and biotechnology markets, in particular sterile products. Skilled in developing and implementing strategic remediation plans, for example those aimed at DHF completion and CAPA compliance, including completion of verification, validation and effectiveness actions. Gerry has an excellent track record in Quality Systems, Validation and Risk Management projects in Medical Industry projects. Recent projects have included; Design History File remediation, Risk Management according to ISO 14971, preparation and updating of pFMEA, dFMEA, Risk management Plans, Risk management reports, and change control optimisation for deviations. Gerry implements a hands on approach to problem solving, project development and remediation activities.

John Lafferty

John Lafferty is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry. John joined SQT as a tutor in 2007. Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and Regulatory Systems. John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting. “It is great to be able to bring this knowledge, and the experience gained from ongoing involvement with Life Sciences companies, into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices. As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

John holds the following qualifications: a Bachelor of Technology in Manufacturing Technology, a Six Sigma Black Belt, a Certificate in Training & Continuing Education and a Certificate in Quality Management. John is a member of the following committees relating to Risk Management of Medical Devices; ISO TC 210 – Medical Devices Technical Committee and CEN/ISO JWG1 – Joint Working Group on Risk Management.

One of John’s greatest achievements, in recent years, has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.

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