FREE ON-DEMAND WEBINAR

Key regulatory insights for US and EU market access

Bringing a medical device to market in the United States or European Union—or both—requires navigating complex and evolving regulatory frameworks. Understanding the similarities and differences between FDA and EU MDR requirements can significantly improve your ability to plan effectively, avoid costly missteps, and accelerate time to market.

In this webinar, regulatory experts will break down the essential requirements, strategic considerations, and practical tips you need to confidently move through the approval process. Whether you're launching in a single region or pursuing dual market entry, you'll walk away with actionable insights to strengthen your compliance strategy.

Specifically, this webinar will cover:

• Key regulatory requirements for medical devices in the US (FDA) and EU (MDR)

• The biggest similarities and differences between FDA and EU MDR frameworks

• How to align product development and QMS processes for smoother approvals

• Supplier selection strategies to support compliance from the ground up

• Best practices for clinical trials and evidence generation across both markets

• Navigating regulatory pathways with a risk-based, documentation-ready approach

• Opportunities to streamline compliance for dual market entry