How to Deal With the New Post-Market Surveillance Requirements Under Regulation (EU) 2017/745
Автор: NSF
Загружено: 2019-06-10
Просмотров: 3258
Описание:
This webinar relates to the new Medical Device Regulation 2017/745 that replaces the EU’s current Medical Device Directives (93/42/EEC and 90/385/EEC).
Industry expert Yue Li provides insights into how post-market surveillance is conducted and you will learn about the:
• Interpretation of the new requirements of MDR
• Requirements of post-market surveillance
• Interface of PMS and technical documentation
• Post-market clinical follow-up
Yue Li, M.SC., is a consultant for regulatory affairs and project management at PROSYSTEM, an NSF International company, with several years of professional experience in the field of clinical and regulatory affairs. Her professional focus is on the clinical evaluation and international registration of medical devices. She is an expert in the implementation of Medical Device Regulation 2017/745. She holds a master’s degree in manufacturing engineering and a bachelor’s degree in biomedical engineering.
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