Are you a Dutch Life Sciences & Health entrepreneur looking to take your innovative solution global? In your international expansion you might face the challenge of navigating complex regulatory frameworks, including the European Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA) approval. Join the Health~Holland Knowledge session on Regulatory Approval and learn from subject matter experts from MedEnvoy Global on MDR / FDA approval.
When: 5 June 2025, 15:00 – 18:00
Where: Microlab, Rotterdam
For: Dutch Life Sciences & Health (LSH) companies
Organizing parties: MedEnvoy Global, Health~Holland, Task Force Health Care
Why
Dutch Life Sciences and Health (LSH) companies seeking to expand internationally face the challenge of navigating complex regulatory frameworks. The European Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA) approval processes are critical milestones for market access. Understanding these regulatory pathways is essential for successful product internationalization and ensuring patient safety worldwide.
What to expect?
Join our Health~Holland Knowledge session to gain valuable insights into obtaining MDR and FDA approvals for your innovative healthcare solutions. Our expert-led discussion will cover the latest updates on regulatory requirements, explore best practices for engaging with notified bodies, and provide guidance for navigating the certification process in both Europe and the United States. This session will equip you with the knowledge to overcome regulatory hurdles and accelerate your global market entry.
Curious to learn more about regulatory approval in Europe and the United States?
More about the program will be announced shortly.
Source: Task Force Health Care