Ypsomed provides end-to-end design verification services to ensure every device meets regulatory, technical, and performance expectations. Our in-house capabilities support faster, more reliable product development, whether final assembly is performed internally, or managed by selected external partners or the customers themselves. Pre-qualified and modular, Ypsomed platforms are developed with verification in mind. Our verification programs follow established protocols to confirm performance and compliance while enabling customization.
ISO-compliant testing facilities
Our certified laboratory operates in accordance with ISO 11608, GMP and global regulatory expectations. These facilities are purpose-built to support combination product development across multiple regulatory regions. We use automated test equipment to reduce processing times as well as the number of required test samples. Advanced analytical tools, including high-speed cameras, force and pressure sensors, and x-rays scans support root cause analysis to help diagnose performance deviations. This is complemented by real-time and accelerated ageing capabilities.
In-house final assembly for DV
To fast-track design verification, we operate semi-automated lines for final assembly. These systems support multiple Ypsomed platforms and feature monitored inline quality control, improving traceability, repeatability, and lead times. This setup avoids the global shipment of DV samples, optimizing for time and costs.
Full-service design verification support
We offer comprehensive design verification support, including test matrix design, protocol development, mechanical and functional testing, dose accuracy measurement, and reporting aligned with FDA, EMA, and other authority requirements. Secure drug sample cold storage and handling are also provided.
