WEBINAR | How to best interact with a Notified Body for a successful MDR Application

October 17, 2024

Hosted by ASPHALION, in this webinar we will explore the intricate processes involved in the qualification and classification of medical devices (MDs) under the Regulation (EU) 2017/745 or MDR. Additionally, we will provide a detailed overview of the conformity routes available under MDR, providing guidance through the compliance landscape to ensure MDs meet the stringent European legislation.

Our partner for this webinar, BSI, will discuss key updates regarding BSI Group and BSI Regulatory Services, including general information about Notified Bodies (NBs). The BSI Application Portal and the guidance available for users will also be covered. Additionally, we will outline the MDR process and associated timelines, providing a comprehensive understanding of the steps involved in the regulatory pathway.

 

Join BSI expert Pilar Maldonado and Asphalion expert Koldo García in this webinar, where they will go through the following topics:

 

  • ASPHALION Regulatory Affairs consultancy – MedTech services
  • Qualification and classification of MDs under MDR
  • Conformity routes under MDR
  • BSI GROUP & BSI Regulatory Services
  • General NB update
  • BSI Application portal & guidance
  • MDR process & timelines

 

For further information, feel free to contact us at: [email protected]

 

 

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