Legal
Regulatory status.
A plain-language summary of where our devices and software sit in the regulatory landscape.
Quality system
Our quality management system is built around ISO 13485:2016, the international standard for medical-device quality management.
Devices and intended uses
The Proxima device is undergoing conformity assessment with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for multiple intended uses. Availability in any given indication is limited to authorised investigational, clinical-trial or post-CE/UKCA settings until conformity is granted for that indication.
Software
Health Hub software components fall within Software as a Medical Device (SaMD) scope for their intended uses, and follow the relevant IEC 62304 and ISO 14971 standards.
Data and clinical evaluation
We maintain a clinical evaluation plan and report aligned with current MHRA expectations. Analytical and clinical performance data are generated under controlled study conditions and made available to regulators on request.
Contact
Regulatory or quality enquiries: changetheworld@immunealgorithmics.com.