ETHOS is a company driven by a passion for high quality and effective digital health products and services.The team provide a depth of expertise across the core domains needed for the safe, secure and effective deployment of digital health focused technology at scale. Each member of the team has more than 15 years NHS & health sector experience including clinicians and senior leaders working nationally and internationally.

We proactively support our professional bodies to improve standards and influence sector workforce development. As subject matter experts we strive to contribute to the industry via our professions as part of our charter.

All our work aligns to international standards and themes for digital health interventions, which makes us globally appealing for entry to and from the UK to other emerging markets:

Information and Cyber Security

Clinical Safety

Digital Effectiveness

Medical Devices

Audit & Compliance

Training and Events

Digital Technology Assessment Criteria – DTAC

Innovation Partnerships

Services we offer

  • Clinical Safety
  • DTAC - Digital Technology Assessment Criterea
  • Medical Devices
  • Information Governance
  • Information Security

Support we offer

Strategic Business Development & Strategy – ETHOS can help you define your Regulatory Strategy. Such a strategy must encompass all relevant legislation, standards, and regulations. Collaborating with ETHOS ensures a streamlined strategy that minimises duplication of effort and expedites the compliance journey.

UK NHS Entry – We are experts in UK NHS market entry through the Digital Technology Assessment Criteria (DTAC) and Clinical Safety standards.

Digital Technology Assessment Criteria (DTAC) – Expert Assistance. The ETHOS approach to DTAC provides you with confidence your supporting evidence passes review from UK NHS commissioning organisations first time and without issue.

UK NHS CLINICAL SAFETY – UK NHS have published standards for clinical risk management of digital health systems and are mandatory for health and care in the UK Compliance with these standards has never been more important for UK NHS market entry. Implementing the Clinical Safety standard can be daunting and complex for innovators & manufacturers of medical devices alike. ETHOS CEO Stuart Harrison co-authored the standards and continues to lead their next stage development internationally!

UK Clinical Safety Officer – ETHOS provides Clinical Safety Officers who are suitably qualified and highly experienced health care practitioners.

Information Security Compliance – The team collaborate regularly with regulatory bodies and professional standards organisations to influence best practice across the health and care sector. Compliance work includes: ISO 27001 – ISMS, Cyber Essentials / Plus certification, Cyber Security Health Check, Data Security and Protection Tool Kit (DSPT) certification, GDPR – Compliance Training.

Virtual CISO / DPO – There are no hidden charges, and we only remain engaged until you have gained your certification, and your staff have the knowledge and confidence to operate and maintain the safety system unless you select our ETHOS Virtual role deployment option.

Medical Device Regulatory Support – Medical Device and IVD companies necessitate the expertise of specialist subject matter experts to ensure compliance with prevailing legislation and standards. ETHOS offers expertise in: Regulatory Affairs, Remediating audit findings, Device development, Quality Management Systems, Verification & Validation, Supplier Representation, Person Responsible for Regulatory Compliance, EU Representative, EU Free Sale Certificate, Technical Documentation, Risk Management, Clinical Investigation & Evaluation, Harmonized Standards compliance, Product Design, Recalls & Adverse Event Support, Post Market Follow Up, UK Responsible Person, UK Importer Service, FDA Certification (US)