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Technical Documentation with the new Medical Device Regulation EU MDR 745/2017
- Quality management processes additional to the SO 13485:2016 quality management standard for medical device companies
- Requirements in comprehensive product documentation in a global market e.g. Canada, Australia, Europe
- Maintenance of a STED-File
- First Setup of a STED-File
Overview of the webinar
The STED-File with the special format as technical documentation covers a lot of countries and helps to have technical documentation in global acting companies. A STED-File collect all the data’s and can help you to keep the overview to deal with this format regarding the several requirements in countries, which required STED-Format e.g. Australia, Canada, etc. Another topic is how to deal with the STED-Format regarding the new EU MDR File Format in Europe and how to convert or work with a mapping table to be prepared for technical file submissions beginning this summer 2019 in Europe. This webinar will show, how to plan and conduct a gap analysis, an action plan and how to be on track with the first setup and maintenance of the file. A STED-File connects the quality management department and the regulatory affairs department. The STED-File-Format requires activities in both areas. Technical documentation and quality management are strongly connected e.g. in the processes post-market surveillance, post-market clinical follow-up, clinical evaluation, risk management, technical documentation, complaint management, vigilance.
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 you attend?
You should attend to learn more about the STED-File as technical documentation and how to deal with this format regarding the several requirements in countries, which required STED-Format e.g. Australia, Canada, etc. Another topic is how to deal with the STED-Format regarding the new EU MDR File Format in Europe and how to convert or work with a mapping table 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 STED-File-Format requires activities in both areas. Technical documentation and quality management are strongly connected e.g. in the processes post-market surveillance, post-market clinical follow-up, clinical evaluation, risk management, technical documentation, complaint management, vigilance.
Faculty - Prof.Dr. Dr. h.c. Frank Stein
Prof. Dr. Dr. h.c. Frank Stein, medical & physical engineer, medical engineering experience since 25 years, food experience since 6 years with HACCP, IFS 6.1, BRC 8, FSSC22000, risk management experience since 15 years, experience with borderline products food-medical, international project and regulatory consulting experience in EMEA, APAO, LATAM, US.