Combining Machine Learning
and Clinical Innovation.

Tech

An End-to-End Healthcare Platform

Product

- UKCA/CE marked Medical Device
- Adapted to Clinical Workflows

Clinical Intelligence

- Clinically led and validated algorithms
- Natural Language Processing and Machine Learning technique

Data Cleaning Pipeline

- Processing multiple ontologies (eg SNOMED CT)
- De-identification and secure real-time Ingestion

Integration

- Connecting to full medical records for 96% of UK Population
- First in the UK to have full read and write functionality

Vision

Electronic Health Record Data can
Industrialise and Humanise Medicine.

Safety

Safe & Compliant Platform

UKCA | CE mark achieved

The UKCA and CE mark for a Software as a Medical Device (SaMD) confirms that the product undergoes verification and validation testing, risks are evaluated and mitigated, and that clinical evidence is collected. There is also an ongoing process for post marketing surveillance and quality assurance. This confirms that our clinical decision support software meets the standards for safety and performance for medical devices in the UK and EU, enabling its commercialisation in these markets.

HSCN Network

Abtrace is connected to the HSCN, a private network for healthcare and social care data. Patient data is transmitted to Abtrace over the HSCN.

ISO13485:2016 Certification

This international standards certification requires a quality management system (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

This required a two stage on-site audit with ongoing surveillance covering the life-cycle, including design and development, production, distribution, installation, and servicing of an AI based medical device and provision of associated activities.

Data Infrastructure penetration tested

Conducted by a CREST approved provider, this test asked an independent group of experts to attempt to breach our data infrastructure in an attempt to discover unknown high-risk vulnerabilities. No such issues were identified.

ISO27001:2013 Certification

This international standards certification requires a two stage on-site initial audit with ongoing surveillance assessments by Lloyd’s Register to assess the Information Security Management System (ISMS) for the management and delivery of software solutions and supporting data infrastructure.

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