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.
- May 2021
UKCA | CE mark achieved
UKCA | CE mark achieved
May 1, 2021 - Jul 2020
HSCN Network
HSCN Network
July 2, 2020Abtrace is connected to the HSCN, a private network for healthcare and social care data. Patient data is transmitted to Abtrace over the HSCN.
- Jan 2020
ISO13485:2016 Certification
ISO13485:2016 Certification
January 2, 2020This 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.
- Sep 2019
Data Infrastructure penetration tested
Data Infrastructure penetration tested
September 30, 2019Conducted 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.
- Aug 2019
ISO27001:2013 Certification
ISO27001:2013 Certification
August 18, 2019This 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.
- Jul 2019
Cyber Essentials Certification
Cyber Essentials Certification
July 17, 2019Cyber Essentials is a government-backed, industry-supported scheme to help organisations protect themselves against common online threats. The government requires all suppliers bidding for contracts involving the handling of certain sensitive and personal information to be certified against the Cyber Essentials scheme.
Abtrace has been certified by IASME as meeting the required standards for software and systems to protect against cyber threats.
- Jul 2019
NHS Data Security and Protection Toolkit
NHS Data Security and Protection Toolkit
July 11, 2019All 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.
- May 2019
GDPR Compliant
GDPR Compliant
May 1, 2019The General Data Protection Regulation alongside the Data Protection Act 2018 require organisations to store and process data in accordance with the rights, obligations and principles of autonomy, transparency and confidentiality. Scheduled data protection impact assessments (DPIAs) identify risks, mitigations and responsibilities to ensure that the minimum amount of data is held for clearly defined purposes.
- Apr 2019
ICO Registration
ICO Registration
April 1, 2019The 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.
- Aug 2018
Abtrace Incorporated
Abtrace Incorporated
August 1, 2018
