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, audited and maintained against the frameworks that govern medical devices and health data in the markets we serve.
Device regulation, quality management, privacy and security work together, with patient data at the centre.
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 and regulatory status apply to specific products and markets. Data-protection arrangements depend on the deployment.
Regulatory status applies to a specific product, configuration and version. The applicable declaration of conformity and instructions for use define that scope.
The Respiro app brings together inhaler use, symptoms and everyday context. A compatible sensor adds automatic logging and inhalation-technique feedback. The applicable product documentation covers the features available in each configuration.
Respiro Hub brings shared patient records into one view for care teams. Inhaler use and technique can be reviewed together, while programme updates support day-to-day administration. The interface presents recorded information without recommending treatment changes.
Use the instructions for your product and version for its intended purpose, setup and use. For declarations of conformity and supporting documentation, contact our team with the product and market you are interested in.
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.