GroundworkDigital health and medical device teams
Get NHS DTAC-compliant in days with our AI compliance agent.
Keep costs low, without a £12,000+ consultancy quote. In days, you can draft the NHS DTAC 2.0 form, including the clinical safety case, Class I medical device, and US healthcare privacy (HIPAA) documents that you can rely on, keep up to date, and stand behind if you are audited.
How it works
A chat-based AI agent
Groundwork drafts your documents, updates them when something changes, and collects evidence from the tools you connect. You can edit any document yourself. Nothing is published until you approve it.
Self-serve by default
Run it yourself in chat, with the checks built in.
Expert help when you need it
Guided setup, document import, and a review with our team when you want someone alongside you.
Clinical safety officer
A registered clinician to review and approve the clinical safety case NHS DTAC asks for, and the hazard log. You pay for that review, not a drafting project.
Connect your tools and assets
Connect the tools you already use. Groundwork keeps your list of tools and assets ready for you to review.
Evidence from the tools you already use
Connect GitHub, Linear, Microsoft, and more. Groundwork collects evidence from them and checks that those tools and assets are set up the way your documents say they are.
The documents you get
One set of documents, sized to your organisation and the rules you need to meet. Describe a change in chat, and Groundwork proposes the same edit across every policy, list, and log that mentions it.
Policies, privacy notices, and customer agreements
Privacy notices, information security policies, and data processing agreements (the contract that says how you handle a customer's data), written for your actual setup.
Registers and logs
Lists of the personal data you handle, the suppliers and software you use, the risks you track, and clinical safety hazards.
Issues, fixes, and changes
A record of what went wrong, how you fixed it, and the changes you made, so the affected policies and logs stay in step.
Staff reading and regular reviews
Staff can record that they have read and understood a document, and a task list tracks reviews, audits, and submissions.
Customer- and auditor-ready PDFs
Clean PDFs with a version number and a history of who approved each change, ready to send to a customer, NHS buyer, or auditor.
How the options compare
Most compliance options charge thousands a year before you have documents you can send. Groundwork gives you the requirements, built-in checks, and an AI editor directly.
Traditional consultancies
£8,000 to £25,000+
You + Consultants
Pay thousands for meetings and generic templates, handed back weeks later as files that do not update themselves.
AI-assisted consultancies
£3,000 to £12,000+
You + Consultants + A little AI
Yearly subscriptions for interactive web based platforms with AI assistance.
Groundwork
Self-serve
You + AI Agent + Consultants (optional)
Use an AI agent to draft, understand, approve, and use your own compliance documents in hours, then keep them up to date effortlessly.
Questions
How Groundwork drafts, checks, and keeps your policies and records up to date.
Does the AI publish documents on its own?
No. It writes drafts. You save a record or a log, or send a policy for approval. Nothing goes live until you, or the right person on your team, approves it.
Do I need compliance experience to use Groundwork?
No. Groundwork is built for small teams with little or no compliance background. It drafts from your setup, explains what belongs in each list or log, and shows what needs doing and when.
Who approves the clinical safety case?
A registered clinician approves the clinical safety case NHS DTAC asks for: the document that sets out why the product is safe to use. Groundwork drafts that case, the clinical safety log, and the risk plan from your product. The clinician approves them. If you bring in an external Clinical Safety Officer, you pay for that review and approval, not a £12,000+ drafting project.
Can I send a document to an auditor or a customer?
Yes. Any published version exports as a clean PDF, with its version number and a history of changes, ready to send to a customer, an NHS buyer, or an auditor.