Over the PRESSURO project, significant strides were made in the technical and scientific domains, culminating in the successful development and validation of a market-ready medical device system. These achievements represent a cohesive effort to meet regulatory requirements, refine technological capabilities, and ensure scalability for clinical and commercial success.
The development and design freeze of the hardware and software solutions were key milestones. The PRESSURO Sensor Probe and Sensor Data Logger were meticulously engineered, encompassing all components required for functionality, safety, and regulatory compliance. Each unit underwent rigorous performance, safety, and EMC trials, both as standalone products and as integrated components, ensuring seamless operation within the complete PRESSURO system.
Concurrently, the software solution was finalized with robust data pipelines enabling automated data exchange, storage, and processing through its services. Security features, including identity access management and disaster recovery strategies, were implemented to safeguard clinical data. APIs were developed to ensure ease of interpretation for clinicians, while PRESSURO-UX, a real-time monitoring tool, is on track for release in 2025.
The verification and validation process was pivotal in ensuring PRESSURO’s compliance with safety, efficacy, and quality standards. Biocompatibility testing for the PRESSURO Sensor Probes was rigorously conducted in accordance with standards, FDA and MDR regulations. Preliminary evaluations were supported by external experts, with final chemical characterization and toxicity reports been prepared by independent third-party laboratories. Electrical safety and electromagnetic compatibility (EMC) were successfully verified in compliance with world-wide standards, confirming PRESSURO’s readiness for both clinical and home-use environments. Sterilization protocols were validated ensuring safety and reliability for patients and doctors alike.
Design transfer and preparation for production marked another major accomplishment. A risk-based approach guided the selection of suppliers and subcontractors, with quality agreements established for critical components. Production processes were validated through prototype manufacturing for clinical and verification trials. In-house assembly lines were documented and validated, enabling efficient production scaling. The manufacturing capacity was demonstrated with the assembly of numerous PRESSURO kits.
These technical and scientific advancements were complemented by extensive clinical validation activities, including trials conducted at hospitals in Norway and Germany. Together, the project’s achievements have not only realized the technical and scientific objectives but also established a strong foundation for market entry and long-term success.
