Introduction to MDSAP (Medical Device Single Audit Program)

by | Oct 26, 2023 | Upcoming Trainings

Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director

Date: January 31st 2024, Online

Duration: 4 hours | 7:00 – 11:00 AM (EST), 1:00 – 5:00 PM (CET)

About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer with 5+ years of experience within the medical device industry in product development and quality & regulatory affairs. Koushik supports our courses related to quality and regulatory affairs, deploying QMS according to ISO 13485, ISO 27001, MDR/ IVDR, integrating MDSAP, GMP requirements and in the preparation of technical documentation of medical devices for global regulatory submissions. Koushik is an ASQ-certified Medical Device Auditor (ASQ-CMDA) and holder of RAC Devices from RAPS.

Training Objectives:

  • Creating awareness by understanding the principles and approach of the MDSAP program
  • Explain the structure and scope of the Medical Device Single Audit Program (MDSAP)
  • Understand the main requirements of the MDSAP audit processes and their interrelationships
  • Understand the legal framework for medical devices in MDSAP jurisdictions

Training Content:

  • MDSAP History and Introduction
    • MDSAP statement of cooperation
    • MDSAP members
    • Regulatory Authority Council (RAC)
  • Regulatory landscape in MDSAP territories and outcomes
    • Benefits of MDSAP
    • Overview of the regulatory landscape in MDSAP territories
  • MDSAP structure and scope
    • MDSAP Audit cycle
    • MDSAP process interactions
    • MDSAP audit approach
  • MDSAP post-audit activities
    • Generalities
    • Non-conformity grading
    • 5-day rule
  • Preparatory steps for successful MDSAP certification

Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive a training certificate)


Attendees are expected to have a solid background in the requirements of ISO 13485:2016.

Who Should Attend:

  • Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and/ or organizations expanding their market reach to jurisdictions participating in MDSAP
  • Middle Management, Regulatory professionals, or anyone interested in conducting and participating in quality and regulatory audits.


EUR 620 including course material and certificate

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