Annuo Health Cloud logo Annuo Health Cloud Closed-loop • Compliance-by-design • SaMD
Regulated health-cloud platform

Automate SaMD development — in a closed-loop, compliance-by-design structure.

Annuo Health Cloud compresses the regulated build cycle — from ideation and documentation through deployment and audit readiness — from 12–18 months to a few hours, without compromising safety, traceability, or regulatory integrity.

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Faster to compliant deployment Move from concept → controlled release quickly, with evidence built in.
Lower clinical + regulatory risk Safety controls, traceability, and change control remain intact.
Audit-ready by default Every release produces an evidence pack—no last-minute scramble.
Traceability reqs → risks → tests → releases SOUP/SBOM tracking + change impact Azure tenancy + residency options Auditor Room immutable evidence packets

1) What is the Annuo Health Cloud?

In one sentence

Annuo Health Cloud is a regulated health-cloud platform that automates the development of Software as a Medical Device (SaMD) in a closed-loop, compliance-by-design architecture.

What Annuo generates

  • Application blueprint (what to build, how to prove it, what risks exist)
  • Regulatory documentation (living, traceable)
  • Risk and safety artefacts
  • Controlled deployment pathway and audit-ready evidence packs

The problem

  • Compliance documentation is manual, inconsistent, and written after the fact
  • Clinical safety assurance and change control are fragmented across teams
  • PHI/data governance is uneven and difficult to evidence
  • Pilots proliferate without a reliable path to regulated production
  • Audit readiness becomes a late-stage scramble, slowing releases and increasing risk

Result

Pilot sprawl, slow approvals, repeated rework, and increased clinical, regulatory, and reputational exposure.

The solution: closed-loop automation
define → classify → build → document → test → validate → release → monitor → evidence → iterate

Embedded by design

  • Risk management and safety controls
  • Continuous evidence generation
  • Traceability from requirements → risks → tests → releases
  • SOUP/SBOM tracking and change impact
  • Auditor-ready exports

Outcomes (what our clients care about)

  • Faster path from concept to compliant deployment
  • Reduced clinical, regulatory, and PHI risk exposure
  • Lower cost and time burden for documentation, assurance, and audits
  • Repeatable delivery pattern across multiple apps and departments
  • Evidence packs ready for regulators, payers, procurement, and safety boards

2) The Product

What it does (plain terms)

  • Turns ideas into validated blueprints (scope, classification, controls)
  • Generates living documentation aligned to medical device standards
  • Creates risk and safety artefacts and keeps them current
  • Produces release-ready evidence packs and audit exports
  • Supports controlled change management and post-market evidence

Who it’s for

  • Health systems and hospitals building regulated apps and clinical AI
  • Digital therapeutics and SaMD vendors under continuous change control pressure
  • Payer/provider digital teams needing consistent governance and evidence
  • Academic centres translating research into real-world clinical deployment

Core capabilities

1) Build Wizard (No technical knowledge required)＋
  • Describe intended use, users, data, jurisdictions, and AI involvement in plain language
  • Annuo determines SaMD classification and safety class (A/B/C)
  • Outputs a validated blueprint: APIs, risks, controls, tests, and evidence tasks
  • Generates the deployment-ready scaffold so technical teams start with the right structure
2) Documentation Wizards (IEC 62304 lifecycle)＋
  • Automatically generates and maintains living regulatory documentation: SDP, SRS/SDS
  • Traceability and V&V matrices
  • SOUP and SBOM inventories
  • Change-impact and release documentation
  • Everything remains linked across requirements → risks → tests → releases
3) Compliance & Risk Wizards＋
  • ISO 14971 risk plans/files
  • ISO 13485 alignment support
  • ISO/IEC 27001 security controls mapping
  • ISO/IEC 42001 AI management artefacts
  • IMDRF SaMD classification + clinical evaluation scaffolding
  • Climate, sustainability and data governance documentation where applicable
4) Usability & Human Factors＋
  • Usability/human factors workflows aligned to medical device expectations
  • Traceability between usability findings and risk controls
  • Evidence captured into the audit trail
5) AI Development Suite＋
  • Controlled AI/ML workflow builder
  • Separation of training, testing, certification datasets
  • Model documentation, performance metrics, drift/bias monitoring
  • Alignment to AI governance expectations
6) Auditor & Evidence Suite＋
  • Read-only Auditor Room with immutable evidence packets
  • Exportable technical files (risk file, traceability, SBOM/SOUP, audit logs)
  • Versioned releases + digital sign-off
  • Post-market surveillance hooks and change control

What makes Annuo different

  • Closed-loop compliance: evidence is generated as work is done — no end-stage reconstruction
  • Create here, run here: controlled execution preserves provenance, safety, and liability boundaries
  • Portable data, not code: FHIR data export + artefact export without exposing regulated runtime IP
  • Regulator-first design: built to satisfy auditors and safety boards, not just developers

3) Key Use Cases

Clinical AI from pilot to production

Governed evaluation → validated release → monitored performance with evidence continuity

SaMD / DTx build acceleration

Faster documentation, risk management, V&V planning, and controlled release cycles

Clinical decision support with auditability

Traceable outputs, clear intended use boundaries, and controlled change management

Repeatable delivery across departments

Standardised patterns and evidence packs for multiple regulated apps

Research-to-clinic translation

Turn research outputs into deployable clinical tools with regulator-ready documentation and evidence

4) How it works (Plain English)

Where it runs

  • Works on Microsoft Azure
  • Can be set up to meet your organisation’s data location requirements (e.g., UK, EU, Middle East)
  • Keeps a clear record of who did what, when, and why — and produces audit-ready exports when needed

Core rules (the non-negotiables)

  • Build and run in one place: so the record of decisions and changes stays intact
  • You can take your data and documents with you: we export the data and the evidence packs (so you’re not trapped)
  • Consent and access rules are enforced: data isn’t used outside what’s allowed
  • Every release produces an evidence pack: audits don’t become a last-minute scramble
What’s always included
Access Strong login and permissions
Role-based access and least privilege patterns
Protection Encryption
Data protected when stored and when sent
Proof Tamper-resistant audit trail
Plus monitoring to catch issues early (including AI performance where relevant)

5) Security & Privacy (Plain English)

What we do to protect patient data

  • Data is encrypted and access is restricted to the right people
  • Every important action is logged so it can be reviewed later
  • We support data boundaries so patient information isn’t used outside approved purposes
  • We support region-based deployment so you can meet local requirements

What we give your security/procurement team

  • A short security overview document
  • Standard procurement/security responses (so you don’t waste weeks in back-and-forth)
  • A clear explanation of what gets logged and what can be exported for audits

6) Compliance & Regulation (Plain English)

We support the documentation and evidence that regulated healthcare software needs, including:

  • Software lifecycle documentation
  • Risk management documentation
  • Security documentation
  • AI governance documentation (when AI is used)
Key point
We don’t ask teams to write compliance documents at the end. Evidence is captured as the work happens, so it stays accurate and audit-ready.

7) Implementation Plan (first 90 days)

Days 0–30 Set-up
  • Agree the first 1–3 use cases
  • Confirm who signs off safety, security, and procurement
  • Set up the platform in the right Azure region
  • Configure access, audit records, and evidence outputs
Days 31–60 First delivery
  • Build the first use case
  • Run the initial risk and testing workflow
  • Produce the first evidence pack and release documents
  • Set up monitoring and change tracking
Days 61–90 Scale
  • Turn the first use case into a repeatable template
  • Add a second use case or onboard another team
  • Turn on dependency and update monitoring
  • Establish a regular governance cadence and audit export process

8. Commercials (GBP)

Pricing guidance (Monthly SaaS). Optional one-off per regulated app launch can be scoped.

Enterprise health systems / payers / pharma

£10k–£27k per month
Optional: £20k–£60k one-off per regulated app launch (scoped)
Equivalent annual guidance: £120k–£320k / year

Regional & mid-market providers

£2.7k–£8k per month
Optional: £8k–£24k one-off per app launch (scoped)
Equivalent annual guidance: £32k–£96k / year

Startups & specialist agencies

£2.5k–£10k per month
Optional: £1.5k–£8k one-off per app launch / credits (scoped)

Optional services (fixed-fee packages)

  • Governance and assurance set-up
  • Regulatory submission readiness support
  • Integration and deployment acceleration

9. Procurement Checklist (Plain English)

Get in touch to discuss the launch offer

  • You have 1–3 products you are developing
  • You know which Azure region your organisation requires
  • You know who will own sign-off for safety, security, and procurement
  • You know what data sources you use (EHR integrations, data feeds, etc.)

We can assist with

  • A simple architecture and data flow summary
  • Security and compliance responses ready for procurement
  • A 30/60/90 delivery plan with milestones
  • Pricing and packaging options
  • A clear responsibility split (you remain responsible for clinical claims; we provide the platform and evidence automation)
  • Example evidence packs (so you can see what auditors/procurement will receive)

10. FAQ

Is this vendor lock-in?＋

No. Data and evidence artefacts are portable (FHIR export + risk/V&V/audit exports). The controlled runtime preserves provenance and safety-case continuity.

Who is the Manufacturer of Record?＋

The customer. Annuo provides verified tooling, automation, and evidence workflows. Your organisation remains responsible for clinical claims and clinical evaluation.

Can we deploy within our Azure environment?＋

Yes, designed for Azure-first tenancy and residency requirements.

How do you handle dependency and supply-chain risk?＋

SOUP/SBOM tracking with vulnerability monitoring and change-impact workflows that trigger re-validation and release gates.

How does this accelerate audits and approvals?＋

By generating evidence continuously and producing stamped evidence packs per release—reducing the manual rebuild effort that typically delays approvals.

IP & Ownership (Plain English)

What you own

  • You own your product IP: clinical logic, workflows, UI, branding, and custom business rules you create
  • You own your data: patient and organisational data remain yours
  • You own your regulatory outputs: generated documentation and evidence packs are yours to keep and export

What Annuo owns

  • We own the Annuo platform: the automation engine, libraries, templates, and controlled runtime that preserves traceability and auditability
  • This “factory” produces compliant outputs — it is licensed, not transferred
What you can export (so you are not trapped)
  • Your data (including standard healthcare formats where applicable)
  • Your full documentation set (risk files, test evidence, release evidence packs, audit trail exports)
  • Your compliance artefacts and traceability outputs
Why this model exists
Regulated software succeeds or fails on provenance and change control. If code and evidence are separated, organisations end up rebuilding audit trails and safety cases later — slowly and expensively. Annuo keeps the regulated lifecycle intact.
Liability boundary (clear and simple)
  • You remain the Manufacturer of Record for your regulated product and clinical claims
  • Annuo is a qualified supplier providing tooling and evidence automation to support your regulated development lifecycle
Optional protections
  • Private deployment patterns (e.g., inside your environment)
  • Contractual IP and confidentiality undertakings
  • Agreed export formats and evidence pack standards
  • Escrow-style arrangements where procurement policy demands it

Want to discuss a launch offer for 1–3 regulated products?

Share your use cases, required Azure region, sign-off owners (safety/security/procurement), and data sources—then we’ll map a controlled pathway to first release.

Contact sales View demo