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.

Trainers

Eline Dirven, Medical Device Team Lead

After obtaining a Master Biomedical Sciences at the University of Leiden, she has been working since 2017 within the area of regulatory affairs. First of all, at a legal manufacturer of non-invasive and active Class I and Class IIb medical devices and the last 5 years as a consultant. As a consultant, she gained experience with different medical devices such as substance-based devices (i.e. gels or cream for the skin, nasal sprays, vaginal and rectal gels, stomach tables etc.), implantable devices, wound dressings, dental applications,  reusable surgical instruments, drug-delivery devices, software applications, and devices to improve peoples vision for especially start-up to medium sized companies. Most of her activities were focused on providing support for design and development projects and writing the full technical documentations to place the medical device within the European Union on the market, but also experience with other regulatory markets as United Kingdom, Australia, United States of America, Saudi Arabia, Brazil, and Singapore.

Tiago Fortunato, Regulatory Consultant – Medical Devices

After a scientific career in tissue engineering and immunology, including as a postdoctoral researcher working on pre-clinical development of medical devices (non-biodegradable vascular access graft), he transitioned in 2021 to a role as an R&D engineer for a medical device manufacturer specializing in dialysis and apheresis devices. In this position, he gained expertise in writing user needs, design inputs, and design outputs, among other key aspects of product development. Thereafter, he made the step towards regulatory affairs, with a strong focus on performing risk management and EU and US regulatory strategy plans.

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!