ISO 13485 Quality Management System for Medical Device Industry; How to build a Quality Management System for the European Market?

You should attend this webinar to understand, what are the changes to the previous standard and how to implement the changes in your current quality management system in a simple and quick way.

Prof. Dr. h.c. Frank Stein
Date:
Tuesday, March 26, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502396

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$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

Introduction, who should apply the ISO 13485:2016. Overview about the changes of the ISO 13485:2016. Explaining of each change. Smart and fast ways to implement the changes in your quality management system. Fast track internal audit to approve the changes.

Why should you Attend: You should attend this webinar to understand, what are the changes to the previous standard and how to implement the changes in your current quality management system in a simple and quick way.

Your implementation time should be short and need smart ideas to reach the right level to pass the quality management audit by your certification company.

Areas Covered in the Session:

  • Closer regulatory binding of the ISO to the new EU MDR
  • Adjustments in the management review
  • Responsibilities for outsourced processes
  • Labeling, UDI
  • Changes in the control of nonconforming products
  • How to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems

Who Will Benefit:
  • CEO's,Quality/Regulatory Affairs Manager and Quality Representatives
  • Medical Device Manufacturer
  • Importer
  • Distributors
  • Dealers
  • who work with Europe or Countries, which require ISO 13485


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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