Medical Device Single Audit Program (MDSAP) Awareness (8 hrs)

Course Code: ISO13485-MDSA-03

Medical Device Single Audit Program (MDSAP) is a way to develop, manage, and supervise an audit programme that allows a single regulatory audit of a manufacturer conducted by a recognised Auditing Organisation to satisfy the needs of several regulatory jurisdictions. It is based on ISO 13485 and specific regulatory requirements of participating countries.

  • Know the fundamentals of MDSAP
  • Understand MDSAP Audit structure and core processes
  • Learn MDSAP requirements
  • MDSAP overview and objectives
  • Benefits of MDSAP
  • Goals and strategies of MDSAP audit programme
  • MDSAP requirements
  • Audit process structure and audit task
  • MDSAP non-conformity grading system
  • Impact of audit model to organisation
  • Documentation and reporting

Participants will learn through lectures, case studies, group exercises and discussions.

This course is suitable for:

  • Quality assurance and regulatory affairs professionals
  • Internal auditors
  • Quality engineers
  • Manufacturing engineers within medical device industry

Duration : 1 day (8 hrs)
Time : 9:00am – 6:00pm

Course Fee : $450.00
Nett Fee Incl. 7% GST : $481.50

(A course in partnership with TÜV SÜD)

Key Benefits
  • Know the fundamentals of MDSAP
  • Understand MDSAP Audit structure and core processes
  • Learn MDSAP requirements
Course Contents
  • MDSAP overview and objectives
  • Benefits of MDSAP
  • Goals and strategies of MDSAP audit programme
  • MDSAP requirements
  • Audit process structure and audit task
  • MDSAP non-conformity grading system
  • Impact of audit model to organisation
  • Documentation and reporting
Learning Methodology

Participants will learn through lectures, case studies, group exercises and discussions.

Who Should Attend

This course is suitable for:

  • Quality assurance and regulatory affairs professionals
  • Internal auditors
  • Quality engineers
  • Manufacturing engineers within medical device industry
Course Details

Duration : 1 day (8 hrs)
Time : 9:00am – 6:00pm

Course Fee : $450.00
Nett Fee Incl. 7% GST : $481.50

(A course in partnership with TÜV SÜD)

Course Application

Details Registration
February 21, 2020 - February 21, 2020 (9:00 am - 6:00 pm) Closed