Free Workshop: Preparing For Your Medical Device's Regulatory Strategy Plan
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:
From product information to a clear intended use - Defining what you are bringing to market
Risk classification in order to determine the regulatory pathway - Understanding regulatory categories and their impact
Demo on how to determine regulatory requirements
Quality Management System - What you need from day 1 to ensure a high-quality product
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!
