A laptop screen displaying the AIS A login page with fields for username and password, and options to log in via app stores or Microsoft Entra ID, set against a blue digital background.

AISA® is now an MHRA-registered Class I Medical Device

Achieving MHRA Class I Medical Device status marks a significant milestone in our commitment to clinical safety and regulatory excellence. This registration confirms that AISA® meets the stringent standards required for use within the NHS and wider healthcare sector, ensuring our ambient AI technology is not only innovative but also safe, compliant, and trusted for clinical decision-making.

WHY MHRA Registration Matters

The MHRA (Medicines and Healthcare products Regulatory Agency) governs all medical devices used in UK healthcare. Its approval signifies that AISA® has undergone formal assessment for safety, reliability, and quality under recognised medical device regulations. This provides healthcare organisations and clinicians with the assurance that our AI-driven solutions meet the same high bar of governance and accountability expected of all clinical technologies deployed in patient care.