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.

Date: Tuesday, August 27

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

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.

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