Post by Holland Innovative

MDR & IVDR for Hardware and Software | 12 May 2026 Your pathway from idea to a compliant, market‑ready medical device Turning medical technology into a certified product can be challenging. To support your journey, experts from Holland Innovative, PCV Group, and Evidencio will translate MDR, IVDR, and CE‑marking into practical examples and clear explanations. Directly related to your medical device development, whether you're working with hardware or software solutions. 👀 Lisette van Steinvoren - Stamsnijder and Lisanne Karbaat (Holland Innovative) bring MDR and IVDR to life through a real case, clarifying key concepts such as CE‑marking, intended use, software classification, and the latest update proposal. 🔬 Lili-Marjan Boelens - Brockhuis and Joris Bronkhorst (PCV Group) show how MDR requirements are applied in real product development, using specific examples and practical tools to ensure devices stay compliant throughout the process. 🖥️ Tom Hueting (Evidencio) clarifies when MDR, IVDR, and the AI Act apply to software, showing through examples how intended use shapes classification and market access. We’ll wrap up with a networking lunch, a moment to continue the conversation, connect, and explore new steps together. 𝙋𝙧𝙖𝙘𝙩𝙞𝙘𝙖𝙡 𝙞𝙣𝙛𝙤𝙧𝙢𝙖𝙩𝙞𝙤𝙣  MedTech Twente Building Blocks: MDR & IVDR for Hardware and Software Date: Tuesday, 12 May Time: 09:00 - 13:00 (including lunch) Location: TechMed Centre - University of Twente (Enschede) Language: Dutch 👉 More information and registration: https://lnkd.in/eJDJb8zx MedTech Twente | Saxion University of Applied Sciences | TechMed Centre - University of Twente | Health Valley Netherlands | Kennispark Twente | Oost NL | Erwin Holtland | Manon Bijsterbosch