US or Europe First? Choosing Your Regulatory & Clinical Path

Bringing an innovative medical device to market is about much more than developing great technology. Understanding the regulatory landscape early on can save valuable time, reduce risks and help you make better strategic decisions throughout your product development journey.

In this practical workshop, regulatory experts from Qserve will guide you through the key differences and similarities between the European and US regulatory pathways for medical devices. Through practical examples, you’ll gain insight into how your product is classified, what evidence is required and how to plan your route to market.

During the second part of the workshop, participants will split into two smaller groups, allowing for more in-depth discussions tailored to their specific technology. Depending on the participating startups, the sessions will focus on either software and AI-based medical devices or non-active patient-contacting and higher-risk medical devices.

Whether you are still validating your idea or preparing for market entry, this workshop will help you better understand the regulatory and clinical considerations that can influence your development strategy.

What will you learn?

• The different market access routes for medical devices in the EU and the US
• How to determine whether your product qualifies as a medical device
• Medical device classification in both regulatory systems
• What clinical and technical evidence is required
• How to estimate regulatory timelines, costs and development planning

Speakers

Robert Paassen, Team Manager Regulatory Medical Devices & Senior Consultant | Qserve

Robert has extensive experience in regulatory affairs for medical devices and supports innovative companies in developing efficient regulatory strategies for both European and international markets. During this workshop, he will explain the regulatory fundamentals and help startups understand the key decisions they need to make early in product development.

Additional specialist sessions

To ensure participants receive the most relevant insights, a second Qserve expert will join the workshop based on the technologies represented by the participating startups. Depending on the biggest ask it will be either Coenraad or Bianca:

Coenraad Davidsdochter, Team Manager Regulatory Medical Devices & Senior Consultant

Coenraad specializes in software, AI-based and active medical devices and supports companies in navigating the regulatory requirements for these rapidly evolving technologies.

Bianca Lutters, Director Knowledge Management, Head of Clinical Affairs & Principal Consultant.

Bianca specializes in clinical strategy, implantable and higher-risk medical devices, combining extensive regulatory expertise with deep knowledge of clinical evaluation and evidence generation.

Location
Meet&Greet, Noviotech Campus Nijmegen.

Good to know
The workshop is facilitated in English and is free of charge.

Participation in the workshop is free for everyone, including drinks and bites. However, for noshow and cancellations within 24 hours prior to the event, we will charge a fee of 15 euros (excluding VAT) to cover incurred expenses. By signing up, you agree to this term.