Practical DCB0129 compliance support from experienced NHS clinical safety consultants
The AbedGraham Group provides specialist DCB0129 (DCB 0129) compliance consultancy for organisations supplying health IT systems to the NHS. We help you understand what compliance means in practice, produce the required clinical safety artefacts, and demonstrate proportionate clinical risk management with confidence.
Our consultants support organisations at every stage, from an early gap analysis through to ongoing compliance for live NHS deployments.
Discuss your product, risk profile, and NHS requirements with a specialist.
Our approach to DCB0129 compliance consultancy
We take a pragmatic, proportionate approach to DCB0129 compliance, aligned to your system, clinical context, and organisational maturity. Our consultancy typically includes:
1. Initial gap analysis
We review:
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Your system and intended clinical use
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Existing documentation and processes
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NHS or assessor feedback (where applicable)
This allows us to define a proportionate compliance approach.
2. Clinical risk management planning
We support the development of:
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A Clinical Risk Management Plan (CRMP)
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Defined scope, assumptions, and exclusions
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Clear ownership of clinical risk activities
3. Hazard identification and risk assessment
Our consultants support:
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Identification of foreseeable clinical hazards
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Risk assessment and prioritisation
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Definition of appropriate mitigations
We focus on risks that genuinely matter in real clinical use.
4. Clinical safety documentation
We will then produce:
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Hazard Logs
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Clinical Safety Case Reports
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Supporting clinical safety evidence
Documentation is written to be clear, defensible, and aligned to NHS expectations.
5. Clinical Safety Officer (CSO) support
As part of ongoing DCB0129 compliance, we provide:
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A named Clinical Safety Officer
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Clinical oversight and sign-off
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Ongoing support for change and deployment
Learn more about our Clinical Safety Officer (CSO) services.
Proportionate DCB0129 compliance
One of the most common misconceptions about DCB0129 is that it requires the same level of effort for every system.
In reality:
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The standard allows for proportionate application
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Risk management should reflect clinical impact and complexity
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Over-engineering creates unnecessary burden without improving safety
Our consultants help ensure your approach is credible without being excessive.
DCB0129 compliance for startups and scale-ups
We regularly support:
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Early-stage digital health companies
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SMEs supplying NHS organisations
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Teams navigating NHS requirements for the first time
Our consultancy approach is designed to:
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Fit around agile development
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Support rapid iteration
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Avoid unnecessary reworking later
How does DCB0129 compliance fit with other NHS requirements?
DCB0129 compliance often sits alongside:
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DCB0160 (deployment and use)
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DTAC and wider assurance processes
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Local NHS clinical governance
Clarity on roles and responsibilities is essential to avoid gaps or duplication. We have decades of experience in navigating all types of local and national procurements for clinical safety activities.
Read more about DCB0129 vs DCB0160 responsibilities.
Common DCB0129 compliance pitfalls
Organisations often struggle with:
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Unclear scope and intended use
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Late involvement of clinical safety expertise
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Overly generic or template-driven documentation
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Weak traceability between hazards and mitigations
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Unclear CSO roles and responsibilities
Targeted consultancy support can address these issues efficiently. We ensure that market-leading documentation is provided to support every required line item of the standard.
When do organisations seek DCB0129 compliance support?
Clients typically engage DCB0129 consultants when they are:
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Preparing for NHS procurement or onboarding
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Responding to assurance or clinical safety queries
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Launching a new health IT product
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Scaling or significantly changing an existing system
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Lacking internal clinical safety or CSO capability
Many organisations seek support after encountering delays or unclear feedback — early engagement usually reduces both cost and risk.
Why Choose The AbedGraham Group?
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Specialist focus on NHS clinical safety and assurance
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Deep experience delivering DCB0129 compliance in practice
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Proportionate, pragmatic consultancy approach
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Integrated CSO and compliance support
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Clear documentation that stands up to scrutiny
Interested in Other ISO Standards?
As leading ISO Standards compliance experts we can support your organisation to navigate a range of technology and cybersecurity requirements.
What does DCB0129 compliance mean in practice?
DCB0129 compliance requires organisations to demonstrate that clinical risks introduced by a health IT system have been systematically identified, assessed, mitigated, and managed. In practice, this means being able to show that:
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Clinical risk management is planned and proportionate
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Clinical hazards are identified and tracked
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Risks are reduced to an acceptable level
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A suitably qualified Clinical Safety Officer (CSO) oversees the process
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Clear, defensible documentation is produced and maintained
Compliance is not about producing documents alone — it is about evidencing a credible clinical safety process aligned to how your system is actually used.
For a full overview of the standard itself, see our DCB0129 guide.