Medical Device Single Audit Program (MDSAP) – How to implement MDSAP in an existing Quality Management System (QMS)?: One Day In-Person Seminar

By: Prof. Dr. h.c. Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbH
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Course Description:

This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.

Learning Objectives:

  • What is the Medical Device Single Audit Program (MDSAP)?
  • Which Companies must have MDSAP?
  • Which Companies should have MDSAP?
  • Which Companies should postpone MDSAP?
  • What are the requirements of MDSAP?
  • How to implement MDSAP in a smart way into a quality management system according ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
  • How the MDSAP-Audit is working?
  • What is the difference between MDSAP and European Notified Body Audits?

Who will Benefit:

Life sciences companies who sell to Australia, Brazil, Canada, Japan or US will be benefited by attending this seminar:

  • CEO and top executives
  • Regulatory Affairs Managers
  • Quality Managers
  • Quality Representatives
  • Other managers, who need to deal with regulatory or quality guidelines

Course Outline

Day One (8:30 AM - 6:00 PM)

  • 8:30-8:59 AM: Registration. Meet & Greet.
  • 9:00-10:00 AM: Introduction into MDSAP (What is MDSAP? Why was MDSAP created? How to attend MDSAP as medical device manufacturer?)
  • 10:00-11:00 AM: MDSAP – Management Processes and Requirements (What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 11:00-12:00 AM: Design and Development Processes and Requirements ((What are the requirements? How to implement the requirements? What are the management responsibilities?
  • 12:00-1:00 PM: Lunch
  • 1:00-2:00 PM: Production and Service Controls ((What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 2:00-03:00 PM: Purchasing (What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 3:00–3:30 PM: Refreshments Break.
  • 3:30-4:30 PM: Production and Service Controls ((What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 4::30-5:30 PM: Market Authorization, Communication with Authorities (Adverse Event Reporting, Field Safety Corrective Actions)
  • 05:30-06:00 PM: Questions and Answers

Meet Your Instructor

Frank Stein
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

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