Course aim

To provide a concise, organization-wide introduction to MDSAP, its purpose and benefits, and the importance of each role in supporting the quality management system.

Course description

The Medical Device Single Audit Program (MDSAP) provides a harmonized approach to auditing a medical device manufacturer’s quality management system. A single MDSAP audit can be recognized by participating regulatory authorities, helping reduce duplication while supporting confidence in regulatory compliance and patient safety.

This short awareness course introduces what MDSAP is, why it matters for global medical device regulation and market access, and how different roles across an organization contribute to an effective quality management system.

BSI’s on-demand courses are available 24/7, allowing you to learn at your own pace and at a time that suits you.

How will I benefit?

This course will help you:

• Understand the purpose and scope of MDSAP
• Recognize its importance for regulatory oversight, market access and patient safety
• Understand the potential benefits of a single audit recognized across participating markets
• Appreciate how activities across the organization support MDSAP readiness and compliance

What will I learn?

Upon completion of this training, you will be able to:

• Outline the purpose and scope of the Medical Device Single Audit Program (MDSAP)
• Recognize why MDSAP is important for global medical device regulation and market access
• Appreciate how you can support your organization in preparing for and complying with MDSAP requirements

Who should attend?

This course is suitable for staff across the organization who need a high-level awareness of MDSAP. It may be particularly useful for:

• Senior management and business leaders
• Quality and regulatory personnel
• Staff working in functions that contribute to the quality management system
• New starters or colleagues requiring general MDSAP awareness

How will I learn?

This is an online, interactive on-demand course. It is available 24/7 and can be accessed from an internet-enabled device.

You can progress at your own pace, take breaks and return to the course during the access period. The course includes narration, reflection, interactive content, knowledge checks and a short test of understanding.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI training course certificate.

Prerequisites

There are no formal prerequisites. General awareness of medical devices/IVDs or quality management may be helpful but is not required.

Further information

Benefits of On-Demand for the individual

Convenient - courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection

Learning pace - You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue

Information retention - During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned

High-quality materials - Developed by top subject matter experts, course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.

Related training

• MDSAP Fundamentals and Readiness training course
• ISO 13485 Quality Management Systems training course