EU MDR Requirements 2021 - DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Topics/Call fo Papers
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation.
The EU's MDR and the Technical File / Design Dossier
Device Classification - U.S. FDA vs. EU MDR
Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
Speaker:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation.
The EU's MDR and the Technical File / Design Dossier
Device Classification - U.S. FDA vs. EU MDR
Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
Speaker:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
Other CFPs
- 【IEEE Xplore、EI、Scopus】2021 International Conference on Machine Learning and Intelligent Systems Engineering (MLISE 2021)
- Employee Handbooks: 2021 Update on Policy and Procedures
- EICompendex.CPCI(Thomson Reuters, Web of Science) 会议/丛书征稿 期刊列表清单
- Boya Century Publishing 英文期刊征文 (列表清单 知网 CNKI收录)
- I International Scientific and Practical Conference «Problemas y perspectivas de la aplicación de la investigación científica innovadora»
Last modified: 2021-05-26 15:16:16