Engage early. Reduce risks. Avoid costly late-stage changes.
Medical electrical device development is complex. Even when devices are tested according to IEC 60601-1, important risks linked to Essential Performance and Single Fault Conditions may remain unidentified or insufficiently documented.
These gaps often become visible late in development or during regulatory assessment, leading to delays, redesigns, additional testing effort or even product recalls.
In this webinar, TÜV SÜD experts will explain why a “testing-at-the-end” approach is not enough. You will learn how Early Stage Testing and Essential Performance Safety Assessment can help engineering and regulatory teams identify safety gaps earlier, align technical and compliance expectations, and reduce uncertainty throughout the development process.
Webinar details
- Moderator: Edoardo Pozzi
- Speakers: Thomas Betzl and Dr. Tobias Beck
Why attend?
Join this webinar to learn how early safety assessment can help you:
- Identify Essential Performance and Single Fault Condition risks earlier
- Understand where safety gaps commonly arise beyond IEC 60601-1 testing
- Align engineering, testing and regulatory perspectives
- Strengthen technical documentation for MDR expectations
- Reduce late-stage redesign, approval delays and additional testing effort
Who should attend?
This webinar is designed for medical device professionals involved in:
- Product development and R&D
- Electrical safety and system architecture
- Regulatory affairs and quality management
- Risk management and compliance
- Medical device testing and certification
Moderator
Edoardo Pozzi
Testing Sales Manager, TÜV SÜD Medical Health Services
