Formative evaluation

Custom Medical

Darmstadt, Germany

Custom Medical – Your Partner for Safe, Intuitive Award-Winning Medical Health Products At Custom Medical, we combine Usability Engineering, UX Design, Software Development, and Compliance Documentation to create safe, intuitive, and inspiring medical and health products. As an ISO 13485 and ISO 27001 certified company, we guide you through the entire development lifecycle - from early usability testing, through final approval, to active post-market surveillance (PMS). We design award-winning. Our UX and UI designs don t just comply with standards - they set new benchmarks. With six Red Dot Design Awards (2019–2023 2025) and the German Design Award (2023 2025), our expertise in human-centered product design is internationally recognized. We test with users internationally. Our cutting-edge test labs allow realistic simulations of low and high-risk medical/health environments - from home use over ORs to intensive care settings. Whether on-site or streamed, we ensure real-world feedback by conducting usability and UX tests with patients, healthcare professionals, and everyday users. Our goal: to refine your product before launch, ensuring it is intuitive, safe, and optimized for real-life use. We document ready for approval. Our team ensures full IEC 62366-1 compliance with structured usability documentation tailored to meet regulatory requirements worldwide. We support you in formative studies, summative evaluations, and post-market usability monitoring, streamlining regulatory compliance across all phases. We develop release-ready. Our software development team translates user insights into compliant, high-performance medical and health applications, ensuring seamless integration with existing systems and regulatory frameworks. From medical devices to digital health products, we create solutions that are safe, intuitive, and internationally recognized. Want to bring an award-winning, user-centered product to market? Let s develop it together!