Built for regulated healthcare from day one, not retrofitted for it.
ACI is Software as a Medical Device, a standalone clinical decision support system. The standards below are the ones it is designed to; they are not completed certifications.
A combined regulatory pathway, tracked openly.
| Standard | Scope | Status |
|---|---|---|
| ISO 13485 | Quality management system for medical device software | Designed to |
| ISO 14971 | Risk management, including hazard analysis for all 102 conditions | Designed to |
| IEC 62304 | Medical device software lifecycle processes | Designed to |
| IEC 62366-1 | Usability engineering for the clinical interface | Designed to |
| ISO 14155 | Conduct of the clinical investigation | Designed to |
| MDR 2017 (India) | Class B under the First Schedule, per CDSCO/MD/GD/MDSW/01/2026 | Proposed |
| EU MDR 2017/745 | Rule 11 classification, Class IIa | Proposed |
Patient data stays inside the hospital.
ACI is designed to operate in conformity with India's Digital Personal Data Protection Act 2023. It runs on-premise with no external cloud dependency, the institution remains the data fiduciary, and patient-identifiable data does not leave its perimeter. Records made available for audit are de-identified.
Every decision, traceable end to end.
Every computation, review event and acknowledgement is recorded with a timestamp and the build version in force. Changes are made only by the manufacturer through a documented change process; ACI never alters its own rules.
NHS Innovation Service
Registered for the NHS market-entry pathway.
Patent filed
Indian patent application No. 567365 filed; US PCT pending.
Hexaware Technologies UK Ltd
Partnership with an established NHS prime contractor holding ISO 27001/27701, Cyber Essentials Plus, ISO 14001, and DSPT credentials.
HL7 FHIR R4 · DICOM
Standard institutional interfaces for laboratory, record and imaging data.
On-premise by design
Runs inside the institution's own servers. Patient-identifiable data does not leave the perimeter.
See ACI at the bedside.
Talk to the team behind ACI about a clinical demonstration, partnership, or due-diligence pack.