Clinical Safety, Information Security and Data Protection support
ETHOS provides comprehensive regulatory compliance services.
Specialist digital health compliance consultancy delivering Clinical Safety Officer services, Medical Device regulatory support, Information Security certification, Data Protection compliance, and training. Serving NHS organisations and manufacturers with integrated regulatory expertise from standards development through certification, accelerating digital transformation whilst maintaining patient safety.
Features
- Clinical Safety Officer services from registered healthcare professional practitioners
- Medical device regulatory compliance experience for UK, and international markets
- Information security management systems implementation and ISO 27001 certification
- Data protection and GDPR compliance with virtual DPO services
- Digital Technology Assessment Criteria support
- CPD-accredited clinical safety training and workforce capacity building programmes
- Strategic Digital Clinical Safety Model for multi-organisation integrated deployments
- Cyber Essentials and DSPT certification for NHS supplier requirements
- Post-market surveillance and medical device vigilance management services
- Virtual CSO, CISO, DPO, and regulatory lead flexible engagement
Benefits
- Reduces time to digital health certification and regulatory approval
- Eliminates permanent Clinical Safety Officer recruitment costs and hiring delays
- Accelerates patient treatment times by thirty percent maintaining safety standards
- Saves organisational costs annually through our strategic model
- Increases NHS operational capacity through efficient and proven workflows
- Builds internal compliance competence through knowledge transfer and training
- Streamlines documentation and automates tracking reducing administrative burden significantly
- Transforms organisational safety culture embedding compliance as business-as-usual practice
- Reduces regulatory compliance risk through standards author expert guidance
- Delivers proven zero adverse events track record
Pricing
- Education pricing available
Service documents
Request an accessible format
Framework
G-Cloud 15
Service ID
2 9 3 6 7 4 0 4 3 0 3 9 4 7 9
Contact
ETHOS DIGITAL HEALTH LIMITED
Stuart Harrison
Telephone: 07485106477
Email: info@ethos.co.im
About your service
- Service categories
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Cloud Support Services
Quality Assurance and Performance Testing
- Assurance/testing design
Service scope
- Service constraints
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ETHOS provides flexible service delivery with no significant constraints.
Services are delivered remotely via MS Teams and online platforms, with on-site delivery available where required.
UK-wide coverage with international capability for multi-jurisdiction regulatory services. Project-based engagements continue until certification achieved and teams are competent.
Clinical Safety Officer services require registered healthcare practitioners. Accredited CSO training courses require participants to be registered health professionals with technology and risk assessment understanding. Services delivered during standard business hours (9am-6pm) with flexibility for urgent requirements. Virtual Officer services require organisational commitment to regular communication and governance processes.
User support
- Email or online ticketing support
- Yes, at extra cost
- Support response times
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ETHOS provides email support with response times tailored to service level agreements and client requirements.
Standard response times during business hours (Monday-Friday, 9am-6pm):
Urgent queries: Within 4 hours
Standard queries: Within 24 hours
Non-urgent queries: Within 48 hours
Weekend and out-of-hours support available by prior arrangement at additional cost for critical regulatory or clinical safety matters.
Virtual Officer service clients receive priority email support as part of their retainer agreements.
All email support channels integrate with client-preferred communication platforms and ticketing systems where required. - User can manage status and priority of support tickets
- No
- Phone support
- Yes
- Phone support availability
- 9 to 5 (UK time), Monday to Friday
- Web chat support
- No
- Support levels
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ETHOS provides three tiered support levels tailored to client requirements:
Standard Support (Included in day-rate services)
Email and online support during business hours (Monday-Friday, 9am-6pm).
Standard query response within 24 hours, urgent matters within 4 hours. Suitable for project-based engagements with defined scope and timelines. Regular planning, reporting, and communication scheduled according to project milestones.
Enhanced Support (Virtual Officer Services - £650-£950 per day retainer) Priority email and ticketing support with dedicated Virtual CSO, Virtual Regulatory Lead, Virtual CISO, or DPO assigned to your organisation. Same-day response to urgent queries, proactive compliance monitoring, and regular status updates.
Includes quarterly business reviews and ongoing regulatory intelligence updates. Technical account manager functionality provided through assigned virtual officer.
Premium Support (Strategic Partnership - Custom pricing) 24/7 critical incident support available by prior arrangement. Dedicated account manager and specialist team allocation.
Out-of-hours and weekend support for urgent regulatory or clinical safety matters. Comprehensive SLA with guaranteed response times. Priority access to senior leadership for strategic guidance. Tailored to large-scale programmes or portfolio manufacturer requirements.
All support levels include knowledge transfer, documentation, and access to ETHOS regulatory tools.
Resellers
- Supplier type
- Not a reseller
Staff security
- Staff security clearance
- Conforms to BS7858:2019
- Government security clearance
- Developed Vetting (DV)
Pricing
- Discount for educational organisations
- Yes
Quality assurance testing (QAT) roles
| Role level | UK Rate | Offshore Rate |
|---|---|---|
| Tester (QAT) | £750.00 | £750.00 |
| QAT analyst | £750.00 | £750.00 |
| Senior QAT analyst | £750.00 | £750.00 |
| Lead QAT analyst | £750.00 | £750.00 |
| Role level | UK Rate | Offshore Rate |
|---|---|---|
| Tester (test engineer) | £850.00 | £850.00 |
| Test engineer | £850.00 | £850.00 |
| Senior test engineer | £850.00 | £850.00 |
| Lead test engineer | £850.00 | £850.00 |
| Role level | UK Rate | Offshore Rate |
|---|---|---|
| Test manager | £950.00 | £950.00 |
| Head of test | £950.00 | £950.00 |
Non-mandatory Standards and certifications
- ISO/IEC 27001 certification
- No
- ISO 28000:2022 certification
- No
- ISO 9001 certification
- No
- Quality management systems (QMS)
- Yes
- CSA STAR certification
- No
- PCI certification
- No
- Cyber essentials
- Yes
- Please provide your Cyber Essentials Certificate Number
- 99c87942-70b9-4f5e-82e6-384942be8e26
- Cyber essentials plus
- No
- Cyber Essentials Alternative
- In relation to the services you do not have a current and valid Cyber Essentials Plus certificate which has been awarded by one of the government approved Cyber Essentials accreditation bodies but you are working towards gaining it, and will be in a position to confirm that you have been awarded a current and valid Cyber Essentials Plus certificate by one of the government approved accreditation bodies within 12 months of the date of award.
- Other security certifications
- Yes
- Any other security certifications
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- Cyber Essential Plus - certification award due March 2026
- ISO 27001 - certification award due Feb 2026
Social value
- Section B - Commitment for Future: Delivery
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Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.
Policy Outcome 1: Fair work: That offers fair wages and good working conditions. Help people get a job, stay in work, and progress in their careers, with good employment opportunities across the country. Notes: Where there is a large proportion of labour costs in the contract, commercial teams should consider MAC in Outcome 1 as a priority
- New or retained jobs on the contract workforce in the relevant area that meet the criteria set out in MAC 1b, 1c and 1d
- Providing opportunities for, and measuring and monitoring of, staff workforce conditions over time, including employee engagement, involvement in decision-making and satisfaction and adapting to any changes in the results, with clear processes for acting on issues identified
- Employment contracts that reflect actual hours worked; steps taken to ensure employees understand their contracts and have the ability to review and adjust them if actual hours regularly exceed contracted hours
- Payment of more than the National Minimum Wage or National Living Wage (as appropriate) to the contract workforce
- Measures to support in-work progression to help people in the contract workforce, to move into higher paid work by developing new skills relevant to the contract
- Support for the contract workforce by providing career advice, and providing opportunities for staff working on the contract with in-work progression career development into known skills shortages or high growth areas
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Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.
Policy Outcome 2: Skills for growth: Supporting growth sectors and addressing skills gaps.
- Activities to support relevant sector related skills growth and sustainability in the contract workforce. Illustrative examples: careers talks, curriculum support, literacy support, safety talks and volunteering
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Mission: Make Britain a clean energy superpower: To cut bills, create jobs and deliver security with cheaper, zero-carbon electricity by 2030, accelerating to net zero
Policy Outcome 4: Sustainable procurement practices: Reducing carbon footprints, minimising waste, and promoting the use of clean energy and green technologies.
- Understanding of opportunities for additional environmental benefits delivery in the performance of the contract, including working towards net zero carbon emissions and use of clean energy and green technologies
- Delivery of additional environmental benefits through the performance of the contract, including working towards net zero carbon emissions and use of clean energy and green technologies
- Understanding of how to influence staff, suppliers, customers, communities and/or any other appropriate stakeholders through the delivery of the contract to support climate and nature protection and improvement
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Mission: Break down barriers to opportunity: By reforming our childcare and education systems, to make sure there is no class ceiling on the ambitions of young people in Britain
Policy Outcome 6: Employment and training: For those who face barriers to employment
- Creation of employment opportunities particularly for those who face barriers to employment, such as prison leavers, care leavers and/or who are located in deprived areas, and for people in industries with known skills shortages or in high growth sectors
- Delivery of training schemes and programmes to address any identified skills gaps and under-representation in the workforce for the contract (e.g. prison leavers, care leavers, kinship carers, disabled people)
- Inclusive and accessible recruitment practices, and retention-focused activities, including those provided in the Guide for line managers on recruiting, managing and developing people with a disability or health condition
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Mission: Build an NHS fit for the future: That is there when people need it; with fewer lives lost to the biggest killers; in a fairer Britain, where everyone lives well for longer.
Policy Outcome 8: Increasing productivity through physical and mental wellbeing: In the supply chain and communities in the relevant area.
- Understanding of issues relating to health and wellbeing, including physical and mental health, in the contract workforce
- Inclusive and accessible recruitment practices, development practices and retention policies that support-focused activities including those provided in the Guide for line managers on recruiting, managing and developing which support people with a disability or health condition
- Actions to invest in the physical and mental health and wellbeing of the contract workforce
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