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Medical Device Single Audit Program (MDSAP): Fundamentals and Readiness

Medical Device Single Audit Program (MDSAP): Fundamentals and Readiness

Level Understanding Duration 2 days
Available to book: Virtual instructor led training £2105 + VAT Book your place

Gain the knowledge and skills required to successfully host a MDSAP audit within your organization.

Obtain in depth knowledge about this new type of audit and how your organization is best prepared to support the completing of requirements within the allotted time. 

Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report. This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.

Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.

How will you benefit?

This course will help you:­­­

  • Improve auditing skills focused on regulatory auditing
  • Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization
  • On completion of this training, delegates will have the:

    Knowledge to: 

    • Demonstrate awareness of MDSAP fundamentals
    • Explain the structure and scope of the MDSAP audit program:
      • MDSAP audit processes and their interrelationships
      • MDSAP and organizational regulatory compliance
      • MDSAP reporting and nonconformity grading
    • Explain the differences between MDSAP and other QMS audits
      • MDSAP and auditing in the medical device industry
      • ISO 13485 and ISO 14971
    • Identify MDSAP documentation


    Skills to:

    • Prepare to host a successful MDSAP audit:
      • MDSAP 7 auditing process requirements
      • Plan audit scopes
      • Analyze data sources required during process audits
      • Analyze control interactions
      • Use correct jurisdictional terminology
    • Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.


    Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.

    • Detailed course notes
    • On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
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