We build connected medical devices, medical-device software and the data platform behind them inside a certified quality system, so the regulatory rigour your patients and partners depend on is engineered in, not bolted on.
Our connected respiratory products and medical-device software are designed, certified and maintained against the frameworks that govern medical devices and health data in the markets we serve.
Protection is layered from the outside in: each shell wraps the one beneath it, down to the patient's data at the core.
Behind every certification is a working system. Three disciplines keep our products dependable from the bench to the patient's hand.
A certified Quality Management System governs how every device is conceived, built and maintained.
Privacy-by-design principles supporting lawful, transparent, and secure handling of personal and health data.
Encryption applied across data storage, transmission, and backup systems.
Certification, regulatory clearance and scope vary by product, configuration and market. Nothing here is medical advice.
Tell us about your deployment and the markets you operate in. We'll walk you through the certifications, data-protection terms and security controls that apply to your use case.