Bringing a medical device to market requires more than just technical development. Without a clear regulatory strategy plan, approvals can be delayed, costs can spiral, and market entry can become a moving target.

This workshop is designed to help startups and scale-ups develop a practical, structured approach to prepare for their regulatory strategy planning.

What’s in this session?

We will guide you through six key steps to build a strong foundation:

1. From product information to a clear intended use  – Defining what you are bringing to market
2. Risk classification in order to determine the regulatory pathway  – Understanding regulatory categories and their impact
3. Demo on how to determine regulatory requirements
4. Quality Management System – What you need from day 1 to ensure a high-quality product
5. Technical Dossier – Focusing on pre-clinical and clinical development plan

This workshop combines essential regulatory insights with a hands-on exercise, where you will actively work through key steps using a structured canvas—ensuring you leave with both the knowledge and clear inputs for your regulatory strategy plan.

We encourage questions throughout the workshop and will address them as we go, ensuring you get practical, relevant insights tailored to your product’s specific challenges.

Who should attend?

• Founders, regulatory leads, and R&D teams in medical device startups
• Teams preparing for their first regulatory submissions
• Anyone responsible for ensuring regulatory compliance in a growing company

Details

• Date: 17th April 2025
• Location: 52 Nijmegen, Novio Tech Campus
• Time: 14:30 – 17:00 (Walk-in from 14:00)

We’ll provide refreshments and cookies to keep you focused and fueled throughout the workshop.

Note that the free workshop is limited to 15 participants. Visit the website register today!