Medical Device Single Audit Program (MDSAP) Awareness eLearning

Medical Device Single Audit Program (MDSAP) Awareness On-demand Training Course

Level Understanding Duration 30 minutes

Available to book: On-demand elearning $49 Book your place

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 gain?

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

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

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