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Medical Device Single Audit Programme

This course covers the Medical Device Single Audit Programme (MDSAP). By the end of this course, participants will have a strong foundational knowledge of how MDSAP works.

Course Details

The aims and learning outcomes of this course are:

  • To develop the skills required for regulatory auditing. 
  • To gain the skills to plan, conduct, report and write nonconformities in accordance with the MDSAP Audit Programme.  
  • To understand the differences between MDSAP and ISO 13485 audits.
  • To understand how MDSAP fits in with other certifications.

Following completion of this course, participants should:

  • Understand the objectives of MDSAP and how it allows a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions.
  • Have a working knowledge of MDSAP’s three-year audit cycle and other possible audits.
  • Understand nonconformity scoring in MDSAP and its programme distinctions.

This is a one day course in which participants will fully engage with the lecturer through group and individual exercises and debate.  There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure. 

This course explores the Medical Device Single Audit Programme and is broken down into four modules.

  1. Introduction to MDSAP and nonconformity scoring.
  2. MDSAP audit approach (1).
  3. MDSAP audit approach (2).
  4. MDSAP audit procedures and forms.