| Website | www.ipn.pt |
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| Address | Rua Pedro Nunes 3030-199 Coimbra Portugal |
Instituto Pedro Nunes (IPN), through its health innovation brand IPN HealthProof, supports organisations throughout the full lifecycle of medical devices and digital health solutions, from proof of concept to validated and compliant products. Its integrated portfolio combines design and development, testing and validation, and regulatory and compliance support for medical devices, helping innovators bring safe and effective technologies to clinical practice and the market.
Design and development services cover intelligent systems, embedded sensing, collaborative and medical robotics, telemedicine technologies, medical device software, digital twins and simulation, developed under ISO 13485-certified processes for the design and development of medical devices for telemedicine and telerehabilitation.
Testing and validation services include feasibility studies, integration and system testing, formative and summative usability engineering (IEC 62366-1), validation with Key Opinion Leaders (KOLs), and pre-clinical and clinical investigations in accordance with ISO 14155. These activities are supported by specialised laboratory facilities and real-world clinical environments through collaborations with hospitals and healthcare partners.
IPN HealthProof also provides specialised regulatory and quality support for medical devices, covering regulatory strategy, CE marking under the Medical Device Regulation (EU) 2017/745 (MDR), AI Act compliance for applicable AI-enabled medical devices, FDA clearance pathways, quality management system implementation (ISO 13485 and 21 CFR Part 820), technical documentation, risk management, clinical and biological evaluation, EUDAMED registration, UDI implementation, and post-market surveillance.
