FREE ON-DEMAND WEBINAR
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!
- Medical Devices
Description
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.
Speaker
Anne-Sophie Grell
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.