REGULATORY
Regulatory status.
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, certified by NQA (certificate no. 175898). Download our ISO 13485 certificate.
Information security
Our information security management system is certified to ISO/IEC 27001:2022 by Peers Quality Assurance Limited (certificate no. 1UK/1/5784697776). Download our ISO/IEC 27001 certificate.
UKCA and CE marks
Algocyte Proxima carries UKCA mark as General IVD. UK Declaration of Conformity.
Devices and intended uses
The Proxima device carries the UKCA mark as a General IVD. Additional intended uses remain under conformity assessment. Availability in those indications is limited to authorised investigational, clinical-trial or research settings until the relevant conformity is granted.
Software
The Algocyte platform (R1) achieved CE mark as a Medical Device. CE Declaration of Conformity.
Other software components are undergoing conformity assessment and current ones are in the process of updating to new regulatory legislation and re-classification.
Contact
Regulatory or quality enquiries: changetheworld@algocyte.ai. Support: support@algocyte.ai