The fastest path to a defensible safety case. Run your hazard workshop, generate your DCB0129 or DCB0160 documentation, and hand off to deployment - without the spreadsheets.
Get your DCB0129 clinical risk management evidence in days, not months.
Run your DCB0160 deployment safety assurance with a clean handshake from the manufacturer.
A short daily email - 5 minutes a day for 14 days - covering everything a manufacturer or NHS deployer needs to know to navigate DCB0129 and DCB0160 with confidence.
Some developers treat DCB0129 and DCB0160 as an after-thought. The result for many is endless word-files, lost hazard-log, and reports that age the moment they're signed.
Reading the standards, drafting the clinical risk management plan, running workshops, then writing it all up. Six weeks at best, often six months.
Severity. Likelihood. Pre-control. Post-control. ALARP. All in a tab somewhere on someone's laptop, drifting from the real product.
The DCB0129 work doesn't translate into the Trust's DCB0160 safety case. Both sides redo the same analysis with no shared truth.
Trygg.Health turns DCB0129 and DCB0160 into a guided workflow your whole team can run. Scope, hazards, controls, ALARP, CRBA, documents - all in one place, all linked, all auditable.
Trygg.Health understands the full lifecycle - from the manufacturer building software, to the NHS organisation deploying it. We've done it, from both sides!
For health tech founders, regulatory leads and clinical safety officers building digital health products that need to land in the NHS.
For NHS Trusts, ICBs, and named clinical safety officers responsible for safe deployment of third-party digital health products.
Each step builds on the last. No retyping. No re-versioning Word documents. No "where's the latest hazard log?" Slack messages.
Pick your workflow - DCB0129 (development) or DCB0160 (deployment) - and add your team.
208 questions with auto-save and conditional logic. AI drafts your intended-use statement.
AI suggests hazards from a curated library. Score severity × likelihood on a 5×5 matrix.
CRMP, Hazard Log, Workshop Reports and Clinical Safety Case Report - PDF, Word, Excel.
5-point eligibility check then a versioned handshake from DCB0129 → DCB0160.
Eleven modules built for the realities of running clinical safety inside a fast-moving health tech team.
Manufacturer, CSO, Deployment CSO and Superuser - each with the right level of access.
Two parallel paths for DCB0129 (dev) and DCB0160 (deployment) with shared lifecycle phases.
208 questions with auto-save, conditional logic and per-component sub-questions.
Workshop prep, AI suggestions, identification, scoring, controls and residual risk - all in one place.
Colour-coded clinical risk visualisation - green, amber, red - for severity × likelihood.
Clinical Risk Benefit Analysis and "As Low As Reasonably Practicable" assessments - only when needed.
CRMP, Hazard Log, Workshop Reports and Safety Case as PDF, Word and Excel - versioned.
10-item checklist gates the safety statement until 100% - no surprises at sign-off.
5-point eligibility check, then a versioned, frozen artefact handed to the deployer.
Assign team members to products with roles. UI alerts when no one is set for a workshop.
Clinical pathways, system interfaces and IT infrastructure - granular CRUD for the real world.
Built-in feedback and contact loops so issues never disappear into a support inbox.
Trygg.Health uses AI to pattern-match against a curated hazard library, draft your intended-use statement, and flag safety-critical features in your questionnaire answers - so your workshop starts at "review and refine," not "blank page."
Clinical judgement stays with your CSO. AI just stops you missing the obvious.
Try the AI workflowGenerate the documents directly from your live data. No re-typing. No version drift. Re-export any time the product changes.
Your CRMP - the spine of your safety case. Personnel, scope and methodology, exported on demand.
Every hazard, control, residual risk and ALARP statement - straight to Excel for review.
Workshop attendees, decisions, scoring rationale and outputs - ready to circulate.
The headline DCB0129 / DCB0160 deliverable - current with the latest product version.
Executive-friendly summary, gated by a 100% compliance check before it becomes available.
Conditional outputs - only generated when residual risk requires them.
Clinical pathways, interfaces and IT infrastructure mapped for DCB0160 deployers.
Versioned, frozen package handed from manufacturer to NHS deployer - auditable end-to-end.
Clinical safety data is sensitive. Trygg.Health is built with the assumption that the wrong person should never see, edit or delete it.
Every login requires a fresh email-verified 6-digit code. No exceptions, no opt-out.
Every database query is scoped to the owning user. Superuser access is logged and limited.
Account deletion cascades cleanly across 31 tables in a single transaction - no orphan data.
Every deployment package is frozen and timestamped - re-issue cleanly when the product evolves.
Plans for solo founders, in-house safety teams, and NHS-adjacent organisations that want a Named Clinical Safety Officer on tap.
Test-drive the questionnaire and hazard workflow on a single product.
Everything in Starter, plus full DCB0129 + DCB0160 workflows and unlimited document generation.
Everything in Team, plus a Named Clinical Safety Officer to sign off your safety case.
Trygg Health was founded by clinicians who have built and deployed digital health software inside the NHS. We made the platform we wished we'd had.
Driven by a passion for digital innovation and clinical safety, Luke co-founded Trygg Health with Simon. Over 15 years in healthcare and HealthTech, with strategic leadership at C-suite and board level steering Trygg from a strategy perspective.
Luke excels at transforming healthcare ideas into market-ready solutions and scaling them for broad impact, forging partnerships with NHS commissioners, patients, elite sports, and corporate stakeholders.
Over the past five years, Simon has designed and deployed software for the NHS, meeting clinical safety standards and streamlining care pathways. He balances pragmatic development with complex regulatory demands across the full software lifecycle.
His expertise covers Clinical Safety Officer duties, DCB0129, DCB0160, Software as a Medical Device, and quality/risk management systems (ISO 13485, ISO 14971). Nearly 30 years in clinical practice and 13 years in leadership across radiology, medicines management and surgical pathways.
DCB0129 is the NHS clinical safety standard for manufacturers of health IT software. If you build digital health software intended to be deployed in the NHS, you need a clinical risk management process - including a Clinical Safety Officer, a hazard log, and a Clinical Safety Case Report - that conforms to it. Trygg.Health implements that process end-to-end.
DCB0160 is the matching standard for the deploying organisation - typically an NHS Trust or ICB. It governs how the deploying CSO assures safe deployment of a third-party product into a specific clinical pathway and IT environment. Our deployment handshake makes the manufacturer-to-deployer transition seamless.
Yes - both DCB0129 and DCB0160 require a named CSO. If you don't have one in-house, our CSO-as-a-Service tier provides a Named CSO from Trygg.Health to facilitate workshops and sign off your safety case.
Most teams move from sign-up to a draft Clinical Safety Case Report in 1-3 weeks, depending on product complexity. The 208-question scope, AI hazard suggestions and auto-generated documents collapse the work that traditionally takes 2-6 months.
Yes. You can paste your intended-use statement, upload your existing hazard log, and use Trygg.Health to keep it living from that point forward. Existing artefacts can be referenced in the document repository.
Data is stored in PostgreSQL (Neon) with per-user isolation enforced at the query layer. Every login requires email-verified 2FA. We do not share your data with any third party except where you explicitly trigger it (e.g. AI hazard suggestions through OpenAI).
No. The AI suggests hazards and drafts language. Your Clinical Safety Officer always reviews, scores and signs off. AI is a research assistant, not a decision-maker.
Set up your first product in under 10 minutes.
