The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body
The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body
Are you submitting a Medical Device under MDR? In this webinar, you will learn more about the main points to consider. Be sure to watch!
On demand
1h
Regulatory Affairs
English
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Description
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.
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
Speaker
Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.
Don’t miss the opportunity to learn and engage with professionals in the field.
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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