Webinar - Wellness App vs Medical Device. Which Side Are You Really On?
Is your software a wellness app, or a regulated medical device under EU MDR? It's one of the most common questions we receive from digital health founders, software teams, and scale-ups preparing for European market entry. Getting the answer wrong can have significant consequences, from unexpected regulatory obligations and delayed market access to costly redesigns of your development and quality processes.
In this webinar, our Regulatory Affairs, Software Solutions, and Quality experts explain where the line between wellness software and Medical Device Software (MDSW) actually sits. Using practical examples, we'll show how seemingly small changes in intended purpose, claims, or functionality can fundamentally change your regulatory obligations.
More importantly, we'll explore what that classification means for your software lifecycle, your quality management system, and your growth strategy as you expand into the European market.
What you'll learn
- How intended purpose, claims, and functionality determine whether your software is considered a wellness application or Medical Device Software (MDSW)
- Real-world examples illustrating the difference between wellness software and regulated medical devices
- The impact of classification on software development, architecture, validation, and applicable standards such as IEC 62304
- How quality system expectations change when software moves from wellness to medical device territory, including risk management, design controls, complaint handling, and post-market surveillance
- Common challenges faced by FDA-cleared and NMPA-approved digital health companies entering the EU market
- Practical considerations for building a scalable compliance strategy without slowing innovation
Speakers
Pieter Smits, Project Governance Lead
Caroline Aernouts, Senior Consultant RA MD