Speaker Profile


Prof. Dr. h.c. Frank Stein

Senior Medical Device Expert, Nemius Consulting GmbH

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

  •  Tuesday, March 26, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
ISO 13485 Quality Management System for Medical Device Industry; How to build a Quality Management System for the European Market?

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.

  •  Monday, April 15, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?

This course will give an introduction into the Medical Device Single Audit Program (MDSAP).

  •  Monday, May 13, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
ISO 62304 How to Create a Medical Software Development File?

This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
ISO 13485 Quality Management System for Medical Device Industry; How to build a Quality Management System for the European Market?

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.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?

This course will give an introduction into the Medical Device Single Audit Program (MDSAP).

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
ISO 62304 How to Create a Medical Software Development File?

This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤390.00
ISO 13485 Quality Management System for Medical Device Industry; How to build a Quality Management System for the European Market?

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.

View All

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