A hazard log built for deployment
Hazards, causes, controls and residual scores in one view, scored and ready for clinical review.
Meet every requirement for
DCB0160
Assuric gives you the hazard log, templates and CSO support to meet DCB0160 for every system you deploy, all in one place.
- Document management
- Manage multiple projects
- Manage supplier documentation
Trusted byhealthcare organisations
Features
Everything you need for
DCB0160
All-in-one compliance
One system for all your frameworks
Assuric is the only platform that covers all your digital health compliance needs as you grow, including UK and EU MDR, NHS compliance, CQC, Information Security and much more.
MCP
Agentic compliance
Seamlessly integrate your existing workflows, agents and tools, to automate everything from security monitoring to incident management.
Expert hands-on support
Expertise and audit-ready
Work alongside clinical safety officers, DPOs and regulatory specialists inside your workspace, with dedicated auditor views.
Document & policy management
Comprehensive onboarding
Hand over your existing documentation and we'll map and upload all of it against your requirements.
Benefits
Clinical safety for every system you deploy
Traceability across hazards, causes, controls and evidence
Every control is linked to causes, evidence and relevant hazards for complete traceability.
Templates for every DCB0160 document
Clinical risk management plan, hazard log and safety case report templates so that you never start from nothing.
A fractional CSO when you need one
We can provide a named clinical safety officer on your project, owning all CSO responsibilities.
What our customers say
“We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!”
Maks Kozarzewski
COO, VitVio
“The Assuric platform is a game changer in the clinical risk management field. It has been carefully designed to make the job of a CSO significantly more streamlined. The team are excellent and responsive to any product suggestions I have requested, and it has been a pleasure to work with them.”
Paul Llewellyn
CCIO, Accenture
“Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!”
Katie Baker
Director UK & Ireland, Tandem
Frequently asked questions
Get in touch if we haven't answered your question below, we are always happy to help!
DCB0160 is a mandatory UK clinical risk management standard that organisations deploying digital health technologies and health IT systems must comply with.
DCB0129 and DCB0160 are overlapping clinical safety standards. DCB0129 applies to manufacturers or suppliers of digital health technologies or health IT systems. DCB0160 applies to the NHS organisations implementing them.
A Clinical Safety Officer (CSO) is a clinician, currently registered with a professional body, who is appropriately trained in clinical safety. In order to become compliant with DCB0160, you must have a nominated individual to act as your CSO. They can be internal or external - we provide expert external CSOs as required.
A Clinical Safety Officer must: Be a suitably qualified and experienced clinician; Hold a current registration with an appropriate professional body relevant to their training and experience; Be knowledgeable in risk management and its application to clinical domains; Make sure that the processes defined by the clinical risk management process are followed. We work with external CSOs who are experienced and confident using our platform to ensure you are compliant as quickly as possible.
DCB0160 expects you to run a clinical risk management process and keep a record of it for each health IT system you deploy. The key documents are a clinical risk management plan, a hazard log and a clinical safety case report, signed off by your Clinical Safety Officer. Assuric has templates for each of these, so you never start from a blank page.
Your supplier does its own clinical safety work under DCB0129 and should share its clinical safety case with you. Your DCB0160 work then looks at the risks of using that system in your own setting. Assuric lets you request and keep track of supplier documentation, including DCB0129 clinical safety cases, alongside your own hazard log.
Yes. You can see what is complete, in progress and not started across every safety task, with owners against each one.
Hazards, causes and controls drafted from your own product documentation, with AI assistance throughout the platform for faster progress.
Built by NHS doctors, certified clinical safety officers, technology experts and software as a medical device regulatory experts.
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Make DCB0160 manageable
across every project
Run every deployment's clinical safety work from one system, with CSO support when you need it.