Health~Holland Masterclass | Regulatory Approval (MDR / FDA)

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.

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 the Health~Holland Masterclass to gain valuable insights into obtaining MDR and FDA approvals for your innovative healthcare solutions. The 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.

Date: June 5, 2025
Time: 15:00-18:00
Location: Microlab, Rotterdam
For: Dutch Life Sciences & Health (LSH) companies
Organizing parties: MedEnvoy Global, Health~Holland, Task Force Health Care

For more information, and to sign up for the masterclass, please click here.

Source: TFHC