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.

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.

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.

All organisations that access NHS patient data must use this tool to provide assurance that they are practising good data security and that personal information is handled correctly.

This allows organisations to measure their performance against the National Data Guardian’s data security standards.

The Information Commissioner’s Office (ICO) is the UK’s independent body that has been set up to uphold information rights in the public interest, promoting openness by public bodies and data privacy for individuals.

Under the Data Protection Act 2018, organisations processing personal data must register on the Data Protection Register. Abtrace is registered under the reference number ZA517064.