Compliance you can prove, from first approval to every batch.
Customised compliance for medical devices and apps. Data integrity for medicines manufacturing. All in your own cloud.
Customised compliance, in one system
We find every rule your product must meet and give you the cloud and quality system to meet them, in your own cloud. Fewer contractors, lower cost, faster approval.
- Compliant cloud and QMS Platform
- Daily proof you're compliant Check
Data integrity you can prove, every day
Every audit-trail entry in your lab and manufacturing systems checked by rules and AI, not a sample. Your QA team decides; your eQMS keeps the record.
- Every entry checked, by rules and AI Assure
- GxP cloud checked daily Check
- Learn across sites, share no data Federated AI
- Predict a scale-up before you run it Digital twin
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 62366-1
- IEC 82304-1
- IEC 81001-5-1
- EU MDR
- UK MDR
- FDA QMSR
- ISO 27001
- UK GDPR
- EU GDPR
- HIPAA
- NHS DSPT
- NHS DTAC
- DCB0129
- Cyber Essentials Plus
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- ALCOA+
Less work, fewer suppliers, nothing missed
For device and app makers
| The usual way | With Arithmia | |
|---|---|---|
| Which rules apply | A regulatory consultant | We work it out for your product |
| Cloud and security | Cloud engineers and a security firm | Ready-made, in your own cloud |
| Quality system | A QMS consultant and a separate eQMS | A QMS built for your product |
| Audit evidence | Gathered by hand before each audit | Recorded every day |
For medicines manufacturers
| Manual review | With Arithmia Assure | |
|---|---|---|
| What gets checked | A sample of entries | Every entry |
| Reviewer time | Hours per batch | Minutes per batch |
| Spotting the unusual | A reviewer's experience | An AI model trained on your patterns |
| When problems surface | At the next inspection | Within days |
| Evidence | Spreadsheets and folders | One pack a month, in your eQMS |
You stay accountable for your quality system and data, and your people make every decision. We give you the tools and the evidence.
Clear prices to get started
Each one ends with your findings, a plan and a quote.
Readiness assessment: health and wellness app
For apps that handle health data but make no medical claim.
- Which rules apply: GDPR, ISO 27001, DSPT, DTAC, Cyber Essentials
- Your compliant cloud architecture
- Roadmap and quote in 3–4 weeks
If your app turns out to be a medical device, this fee counts towards that assessment.
Book an assessmentReadiness assessment: software as a medical device
For apps and software that are medical devices in their own right.
- Which rules apply: ISO 13485, MDR, IEC 62304, ISO 27001, DSPT, DTAC, GDPR
- Your compliant cloud architecture
- Roadmap and quote in 4–6 weeks
Readiness assessment: medical device
For physical devices, with or without software or an app.
- Everything in the software assessment
- Manufacturing, suppliers, labelling and traceability
- Readiness for electrical safety, biocompatibility and sterilisation
Testing itself is done by accredited labs.
Book an assessmentArithmia Assure design-partner pilot
For pharma manufacturers and CDMOs. One place available.
- Runs in your own Azure on one month of audit trails from one system
- Every entry checked by rules, AI and our specialists
- Findings and time saved within the week
In return: your feedback and, if it helps you, a case study.
Apply to joinCommon questions
What does Arithmia do?
We give regulated health and life-science companies what they need for approval and inspection, built into their own cloud. For device and app makers: the cloud set-up and quality system. For manufacturers: a check of every audit-trail entry.
Where do our app and data live?
In your own AWS or Azure account. Nothing comes to us.
Who makes the decisions?
You do. You own your quality system; we supply the tools and the evidence, and your people approve every procedure and decision.
Is Assure an eQMS?
No. It checks your audit trails and sends confirmed issues to the eQMS you already use.
How do we start?
Device and app makers start with a readiness assessment, from £4,950. Manufacturers start with a free one-week Assure trial.
Find out where you stand
A fixed-price readiness assessment, or a free one-week Assure trial for manufacturers.