Regulatory Framework for Medical Devices



Service ID:

Service description

IPN supports startups with robust regulatory support throughout the development and compliance journey of medical devices and IVD. With a core focus on navigating complex regulatory landscapes, IPN ensures that startups meet stringent standards and adhere to legal requirements for bringing innovative medical products to market. IPN offers expertise in various regulatory aspects, including the assessment of conformity, development of the EU declaration, and affixing of the CE marking. The service extends to the implementation of risk management and quality management systems, registrations at EUDAMED, application of the UDI system, and the establishment of post-marketing monitoring systems for medical device surveillance. The service includes a Health technology assessment, utilizing standard surveys like SUS, PSSUQ, and USE. This assessment spans from the paper prototyping stage to pre-market readiness, uncovering issues at an early stage when they are more manageable. The assessment is built on a comprehensive framework with four value pillars: patient value, technical value, allocative value, and societal and economical value. This early technology assessment enables companies to predict the proposed created value of a technology, aligning product development with strategic goals. Taking advantage of IPN's vast experience in the health sector, the service covers areas intelligent sensors and control of dynamic systems, computer vision, embedded systems, human-machine interaction, natural language processing, medical device cyber security and countermeasures, and artificial intelligence of medical devices in the regulatory context, including user interface evaluation service (according to IEC 62366) for medical devices and IVDs during their development.

Medical Devices
Technology Readiness Level
TRL 3 – Experimental proof of concept
TRL 4 – Technology validated in lab
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
TRL 7 – System prototype demonstration in operational environment
TRL 8 – System complete and qualified
TRL 9 – Actual system proven in operational environment
Financial requirements

€395 per day.