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

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.