Medical Device Testing, Validation and Regulatory Services

IPN provides testing, validation and regulatory services to support companies throughout the development and compliance journey of medical devices, from early proof of concept to market entry and post-market activities. These services include support for pre-clinical and pilot studies, clinical investigation management in accordance with ISO 14155:2020, formative and summative usability activities following IEC 62366-1, and electromagnetic compatibility (EMC) pre-testing. IPN also supports the validation of digital health technologies, health software, artificial intelligence and robotics through access to simulated clinical environments and real-world clinical settings, in collaboration with European hospital partners. In addition, IPN provides regulatory and quality support for medical devices targeting the European, UK and US markets, including CE marking, UKCA and FDA pathways, quality management system implementation (ISO 13485, 21 CFR Part 820 and MDSAP), device qualification and classification, development of technical documentation, conformity assessment activities, regulatory registrations, UDI implementation and post-market surveillance systems, covering technology readiness levels from TRL 3 to TRL 9.