Hands-on guidance on regulatory pathways and practical market access in Europe’s MedTech and Digital Health sector
Target Audience: Companies at any development stage with an interest in expanding into the EU market.
Navigating the European regulatory landscape and establishing a strategic presence can be complex, but it doesn’t have to be slow. This webinar introduces the partnership between Munich Medtech, Medical Valley and the R.S NESS Group, offering a practical roadmap to optimise your market presense, regulatory compliance, and secure a strategic foothold in the EU. We will cover the critical regulatory, operational, and financial steps for a successful launch.
Topic |
Key Focus
|
Presented By |
EU
|
· Exploring the scope and opportunities in the European medical
|
Nika Mendelev |
Regulatory
|
· Key regulatory requirements and available market entry pathways for manufacturers |
Gabi
|
Establishing
|
· Practical guidance on navigating different
|
Nika Mendelev |
Bavaria’s
|
· How the Bavarian Ministry of Economic Affairs and its Representative Office in Israel can support your smooth and successful entry into the EU
|
Tina Horsky |
Bavarian
|
· How Medical Valley supports market access in Bavaria
|
Marco Wendel |
Next Steps
|
· Strategies for fast-tracking to Asia, securing German/EU
|
All Speakers |
Managing Director, Medical Valley EMN E.V. & CEO, FastTrack MedTech GmbH
Marco brings over 15 years of dedicated MedTech experience, specializing in innovation management and market access. His expertise is crucial for companies seeking rapid entry and clinical validation in the EU. Previously the CEO of Medical Valley Digital Health Application Center GmbH, he is an authority on evidence generation and the German DiGA application process. Marco will detail the operational support provided by Medical Valley and FastTrack MedTech.
Director of Economy and Technology Bavarian Office in Israel
Tina is a bridge builder for international economic collaboration between Bavaria/ Germany and Israel. Identifying opportunities and synergies between Israeli and Bavarian ecosystem players: startups, Middel stand companies, institutionals and VCs to initiate cross boarder cooperation to further strengthen a prosperous economy, open minded healthy society and ultimately sustainable planet.
CEO of Munich- Medtech
Nika offers critical, hands-on insights into the regulatory and operational aspects of establishing your presence. She will focus on the essential considerations for Representation/Subsidiary site establishment in the EU, guiding you through the practical pros and cons of different market entry models.
VP of Regulatory Affairs, Quality Assurance and Clinical Affairs at R.S.NESS Group
Gabi will illuminate the significant potential of the EU healthcare market and decode the complex regulatory background governing the Life Sciences and MedTech industries. Leverage his knowledge to grasp the strategic opportunities and necessary compliance steps for a seamless European launch.
You can send us questions to info@rs-ness.com
Register Now to secure your spot!
