--- title: "Wellness App vs. Medical Device: Which Side Are You Really On?" description: "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." url: https://qbdgroup.com/en/webinars/wellness-app-vs-medical-device type: "Webinar" language: en published: 2026-07-23 category: "Software Solutions & Services" publisher: "QbD Group" citation: "QbD Group, \"Wellness App vs. Medical Device: Which Side Are You Really On?\", https://qbdgroup.com/en/webinars/wellness-app-vs-medical-device" --- # 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. _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._ 🕐 4 PM CEST / 3 PM BST 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. ## Agenda **Live presentation + Q&A, with live chat and polls** ## 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 A cross-functional team of QbD Group specialists in Regulatory Affairs, Software Solutions, and Quality brings together hands-on MDR, SaMD, and QMS experience to guide you through the wellness-to-medical-device classification decision. ### Pieter Smits Project Governance Lead **Software Solutions & Services, QbD Group** Pieter is a Project Manager at QbD Group, coordinating multi-disciplinary teams to deliver quality and regulatory consulting projects. ### Caroline Aernouts **Senior Consultant RA MD** Caroline is a Senior Consultant Regulatory Affairs at QbD Group, specializing in EU MDR submissions and FDA 510(k) clearances, with deep expertise in software as a medical device (SaMD) and other innovative technologies. ### Judith Prevoo Senior Consultant Quality **Quality Assurance, QbD Group** Judith is a Quality Management expert at QbD Group with 20+ years of experience in ISO 13485 and IVDR/MDR quality systems, helping manufacturers align their QMS with EU regulatory requirements. ## Who Should Attend This session is built for founders, product, regulatory, and quality teams navigating the wellness-to-medical-device classification decision. - **MedTech Founders / CEOs** planning product development direction and regulatory milestones - **CTOs / Heads of Product** navigating IEC 62304, AI/ML compliance, and QMS integration - **VPs / Heads of Regulatory Affairs** defining MDSW classification and CE marking pathways - **QA Directors / Quality Managers** building or scaling ISO 13485 quality systems for software products - **US and China-based manufacturers** planning EU market entry with FDA or NMPA-approved MDSW and AI-driven devices --- Source: https://qbdgroup.com/en/webinars/wellness-app-vs-medical-device — © QbD Group. Quote freely with attribution and a link back.