IPN offers robust testing, validation, and regulatory support to companies throughout the development and compliance journey of medical devices. With a focus on navigating complex regulatory landscapes, IPN ensures that companies meet stringent standards and adhere to legal requirements for bringing innovative medical products to market. The IP Testing and Validation of Medical Devices unit is a reference for the management and execution of testing and experimentation services, supporting the development of digital health technologies in compliance with European standards and regulations. This unit supports the management and implementation of pre-clinical and pilot studies including Clinical Investigation management (ISO 14155:2020), Formative and Summative Usability (IEC 62366-1), and Electromagnetic Compatibility (EMC) Pre-Testing. The unit is also engaged in the creation of world-class reference testing and experimentation facilities for health AI software and robotics in clinical investigation partnerships. It provides SMEs with access to clinical simulated environments and real-world environments in partnership with 11 European hospitals. The IPN Medical Devices Regulatory Support unit (MDRu) provides expertise in implementing regulatory requirements for medical devices, covering CE Marking, UKCA, and FDA processes. The unit supports Quality Management System implementation (ISO 13485, 21 CFR part 820, and MDSAP), evaluates the rationale for the qualification and classification of medical devices, and helps companies in the development of Technical Documentation. Additionally, this unit assists with conformity assessment, development of the EU declaration, affixing the CE marking, implementing risk management processes, registrations at EUDAMED and other applicable databases, application of the UDI system, and establishing post-marketing monitoring systems for device surveillance.