Attend this seminar to learn medical device quality management standard ISO 13485. It will cover 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 is working.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • What are the requirements of ISO 13485?
  • Which Companies must apply ISO 13485?
  • How to implement ISO 13485 in a smart way into a medical device quality management system?
  • How the ISO 13485-Audit is working?

Who will Benefit:

  • CEO’s
  • Regulatory Affairs
  • Quality Managers
  • Quality Assurance
  • Other managers, which need to deal with regulatory or quality guidelines
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Day 01(8:30 AM - 4:30 PM)
  • 8:30-8:59 AM Registration. Meet & Greet.
  • 9:00 -11:00 AM Introduction into ISO 13485 (Overview about this standard, structure, scope)
  • 11:00- 12:00 PM Scope, References, Chapter 4 – Quality Management System
  • 12:00-1:00 PM Lunch
  • 1:00-2:30 PM Chapter 5 – Responsibility of the Management
  • 2:30 – 3:00 PM Refreshments Break.
  • 3:00-4:30 PM Chapter 6 Management of Resources
Day 02(8:30 AM - 4:30 PM)
  • 8:30-8:59 AM Registration. Meet & Greet.
  • 9:00 -11:00 AM Chapter 7 Product Realization
  • 11:00- 12:00 PM Chapter 8 – Measurement, Analyzation, Improvement
  • 12:00-1:00 PM Lunch
  • 1:00-2:30 PM ISO 13485 Audit
  • 2:30 – 3:00 PM What are the expectations of European Notified Bodies?
  • 3:00-4:30 PM Answers & Questions
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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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