Simplifying MDR & IVDR-Overcoming Regulatory Hurdles & Achieving Compliance

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A Masterclass in Streamlining Compliance

Join us for a groundbreaking new webinar that will take a hard look at the complex world of MDR and IVDR compliance and challenge assumptions about high regulatory costs, lengthy review times, and increasing product shortages.

Our expert panel will comprehensively view the current regulatory landscape and the innovative digital solutions designed to revolutionize compliance processes. Learn from industry leaders how to streamline regulatory procedures and achieve sustainable compliance through digital transformation.

Expert-Led Sessions

? Session 1: “Setting the Stage” by Christian Johner, Owner, Johner Institut, GmbH
With 170 consultants, Johner Institut represents hundreds of MedTech manufacturers, both large and small. Christian will discuss the crushing regulatory burden faced by companies and share Johner Institut’s “secret sauce” for modernizing the MDR and IVDR compliance process end-to-end, including standardizing procedures and digitizing documentation.

? Session 2: “Notified Body Perspective” by Johannes Lieback, Managing Director, Berlin Cert GmbH
As head of Berlin Cert, Johannes Lieback brings the perspective of a leading German notified body, detailing the arduous task of reviewing clinical files and technical documentation across various specialties and device classes. He will discuss the importance of automating routine tasks—reducing busywork by up to 40%—to focus on meaningful company interactions and sustainable patient safety.

? Session 3: “Looking Ahead” by Stephen Gilbert, Professor - Medical Device Regulatory Science, News and Views Editor, Nature Portfolio
Stephen Gilbert will discuss recent developments in understanding the need to regulate digital health tools as integrated suites with aggregated and intersecting ‘super’ intended purposes. His talk will highlight the perspectives of the FDA and the UK while addressing the necessary steps for the EU to catch up in this space.

You Will Learn
Understand the current regulatory challenges and the high costs and lengthy review times associated with MDR & IVDR compliance.
Gain Insights into how leading experts and organizations are using digital transformation to streamline regulatory processes and achieve sustainable compliance.

Learn about practical solutions and best practices for automating routine tasks, improving data management, and fostering harmonization across the industry.

Envision a future where regulatory processes are more efficient, transparent, and collaborative, leading to better outcomes for manufacturers and patients alike.

Bring Your Questions
Don’t miss this opportunity to learn from industry leaders and transform your MDR & IVDR compliance approach. Register now to secure your spot and take the first step towards achieving sustainable compliance through digital transformation.