What is the webinar about?
Getting the classification of your device right is one of the most critical steps in preparing a successful submission under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Missteps in defining the intended purpose or indications for use can lead to delays, additional costs, or even rejection of your application.
This webinar will break down the essentials of MDR and IVDR classification rules and show you how to properly define indications for use in a way that aligns with regulatory expectations. Through clear explanations and practical examples, you’ll gain confidence in navigating this complex but fundamental part of the conformity assessment process.
Who should attend?
This webinar series is designed for regulatory, R&D, quality professionals, and founders of startups and small manufacturers. Team members from larger manufacturers seeking a broader understanding of quality and EU regulatory requirements will also benefit from this series.
What will participants gain?
Participants will learn how startups and small manufacturers can accelerate growth by prioritizing quality management and achieving device certification in the EU.
Speakers
