点播网络研讨会

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

In this webinar on demand, we will provide a concise explanation of the process involved in qualifying and classifying a medical device. We will also discuss the most suitable method of conformity assessment to follow and shed light on how a Notified Body conducts audits of your Quality Management System (QMS) and Technical documentation.

Regulatory Affairs

随时观看

60 分钟

Regulatory Affairs

Chinese

Watch our webinar on demand

What you'll learn

Steps for qualifying and classifying a medical device
Choosing the most effective conformity assessment method
Insights into how a Notified Body audits your Quality Management System (QMS)
Key elements of Technical documentation reviewed by a Notified Body

向最优秀的人学习

演讲者

Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.

Anne-Sophie Grell

Manager Regulatory Affairs Medical Devices

Anne-Sophie Grell – PhD in Physics and expertise as a Medical Physicist – brings over 20 years of invaluable experience in the areas of Medical Device Quality Assurance (QA) and Regulatory Affairs (RA). As a seasoned Regulatory Affairs Manager, she has consistently demonstrated her proficiency in navigating the complex landscape of medical device regulations. With her extensive knowledge and comprehensive understanding of the industry, Anne-Sophie is a respected authority in ensuring compliance and driving successful outcomes in medical device regulatory affairs.

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