ISO 14971 - How to Create a Risk File for Medical Devices
  • CODE : TEIN-0002
  • Duration : 90 Minutes
  • Level : Intermediate
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Prof. 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.

The Risk-File according to ISO 14971 and how to deal with this file regarding the several requirements in countries, which require Risk-Files according to ISO 14971 e,g, Europe, MDSAP-Countries (_AUS, BR, CAN, JP, US). Another topic is how to deal with the ISO 14971 regarding the new EU MDR in Europe at 2020 how to be prepared for technical file submissions beginning this summer 2019 in Europe. Learn how to plan and conduct a gap analysis, an action plan and how to be on track. Learn what to go into the quality management department and what to do in the regulatory affairs department. The Risk File according to ISO 14971 requires activities in both areas. Technical documentation and quality management are strongly connected e.g. in the processes R&D, manufacturing, post-market surveillance, post-market clinical follow up, clinical evaluation, risk management, technical documentation, complaint management, vigilance.

This course will give an introduction into the creation and maintenance of risk file documentation according to the ISO 14971. This risk management file is mandatory for technical file submissions in several countries e.g. European Union, MDSAP-Countries (AUS, BR, CAN, JP, US). The introduction will give you an overview about the structure, term definitions, the requirements for the risk management file, the requirements for your quality management system with the interfaces between risk file and processes to your quality management system e.g. post-market surveillance, clinical evaluation, post-market clinical follow up, vigilance, R&D, manufacturing, complaint handling. And the technical documentation, how a smart implementation of the ISO 14971 requirements in the risk management file, the quality management system and the technical documentation is possible and finally how to prepare your risk file reviews by authorities.

Areas Covered    

  • Quality management processes add to the ISO 13485:2016 quality management standard for medical device companies
  • Requirements in a comprehensive risk file as part of the technical documentation in a global market e.g. Canada, Australia, Europe
  • Maintenance of a risk file
  • First Setup of a risk file

Course Level – Intermediate

Who Should Attend   

  • CEO’s of companies
  • Regulatory Affairs Managers of Companies
  • Quality Managers of Companies
  • Quality Representatives of Companies
  • Other managers, which need to deal with regulatory or quality guidelines

Why Should Attend

You should attend to learn more about the Risk-File according to ISO 14971 and how to deal with this file regarding the several requirements in countries, which requires Risk-Files according to ISO 14971. Another topic is how to deal with the ISO 14971 regarding the new EU MDR File Format in Europe at 2020 how to be prepared for technical file submissions beginning this summer 2019 in Europe. Learn how to plan and conduct a gap analysis, an action plan and how to be on track.  Learn, what to do into the quality management department and what to do in the regulatory affairs department. The Risk File according to ISO 14971 requires activities in both areas. Technical documentation and quality management are strongly connected e.g. in the processes R&D, manufacturing, post-market surveillance, post-market clinical follow up, clinical evaluation, risk management, technical documentation, complaint management, vigilance.

  • $179.00



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