Decoding regulatory pathways: How to classify your Medical Device

Join us to understand how different regions categorize medical devices. Ensure compliance and remain empowered with the knowledge to navigate international regulatory landscapes confidently. 

Whether you’re targeting the US market with its FDA requirements or aiming for EU approval under the rigorous MDR, we’ll break down the complexities and provide clear, actionable insights. 

By understanding these classifications, you can streamline your product’s path to market, avoid costly delays, and ensure your device meets all necessary standards.

 

Date: Tuesday, August 27

Time: 10:00 AM - 11:00 AM Eastern Time US

 

 

Webinar Sponsored by:

 

 

Learning Objectives

  • Understand how different regions categorize medical devices & ensure compliance
  • Learn why classification is crucial for regulatory approval and market access.
  • Understand the EU’s key regulations and directives.
  • Gain insight into FDA's 510(k), PMA, and De Novo pathways for US Market Approval.
  • Key insights on rules & requirements for each device classification to streamline regulatory strategy.

 

 

Speaker

 

Ann Vankrunkelsven, RA/QA Manager

Matrix Requirements

 

Ann Vankrunkelsven is a driven and dynamic RA/QA professional who thrives on new challenges and making a positive impact in the world. With a PhD in Bio-engineering, she has always been fascinated by the intersections of science, innovation, and business. After years of honing her skills in Regulatory Affairs and Quality Assurance, Ann has become a true master, often lecturing at Ecole Polytechnique de Louvain.

Currently RA/QA Manager at Matrix Requirements, Ann is a trailblazer who never settles for the status quo. She is passionate about helping customers & businesses succeed with Regulatory Affairs and Quality Assurance & firmly believes that improvement of the quality system and implementation of regulations need to stay practical to be successful. An entrepreneur at heart, Ann built her own business, VR Projects which aims to help global businesses understand Regulatory and Quality Affairs. 

 

Who Should Attend

Companies

  • Medical Device companies
  • Software as a Medical Device companies
  • Medical Device Companies looking to launch a Medical device in US or EU
  • Medical Device Companies Looking to understand Regulatory Classifications of Medical Devices

Job Functions

  • AI Head of RAQA
  • Head of R&D
  • C Suite & Cofounders
  • RAQA Managers
  • Software Developers
  • C Suite Executives launching a Medical Device to market

 

 

Complete the registration form