MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?


Monday, April 15, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 90 Minutes          

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Duration: 90 Minutes  

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You should attend this webinar to understand, what is MDSAP and how is MDSAP working, Also will give an introduction into the Medical Device Single Audit Program (MDSAP).

Prof. Dr. h.c. Frank Stein   Product Id : 502397
  Instructor : Prof. Dr. h.c. Frank Stein

  More Trainings by this Expert


Overview:

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.

Why should you Attend: You should attend this webinar to understand, what is MDSAP and how is MDSAP working.

Your implementation time should be short and need smart ideas to reach the right level to pass the MDSAP - Audit by your audit organization.

Areas Covered in the Session:

  • 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 an 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:
  • CEO's of companies, which sell to Australia, Brazil, Canada, Japan or US
  • Regulatory Affairs Managers of Companies, which sell to Australia, Brazil, Canada, Japan or US
  • Quality Managers of Companies, which sell to to Australia, Brazil, Canada, Japan or US
  • Quality Representatives of Companies, which sell to Australia, Brazil, Canada, Japan or US
  • Other Managers, which need to Deal with Regulatory or Quality Guidelines


Speaker Profile
Prof. Dr. 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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