Everything your device or app needs for approval, in your own cloud
One system instead of a regulatory consultant, a QMS consultant, a security firm and a cloud team. We find the rules your product must meet and give you the cloud and quality system to meet them.
- 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+
Fewer people, lower cost, faster approval
| The usual way | With Arithmia | |
|---|---|---|
| Which rules apply | A regulatory consultant | We work it out for your product |
| Quality system | A QMS consultant and a separate eQMS | A QMS built for your product |
| Cloud and security | Cloud engineers and a security firm | Ready-made, in your own cloud |
| Audit evidence | Gathered by hand before each audit | Recorded every day |
| Who you coordinate | Four or five suppliers | One team |
Your notified or approved body grants approval. We prepare you and your evidence; clinical evaluation and lab testing stay with specialists.
Your app stays yours. Everything around it is ready.
Arithmia Platform
A secure cloud and a quality system from day one, so your engineers stay on the product.
We don't build your app. Platform is the compliant set-up it runs on, in your own cloud, and the quality system it needs.
Where you startYour app
Code, features and data. You own them.
A quality system built for your product
Only the modules your product needs, linked to the evidence below.
A compliant cloud set-up
Encryption, backups, access control, tamper-proof logs and UK or EU data residency.
Daily proof
Every control checked; the evidence filed in your QMS.
Your AWS or Azure account
You own it and host your app there.
Controls in place from day one
| Part | What Foundation sets up | Helps you meet |
|---|---|---|
| Accounts and network | Separate production, test and logging accounts; private network; firewall | NHS DSPT, ISO 27001, Cyber Essentials |
| Data | Encrypted database and storage, automatic backups and restore | UK GDPR, DSPT |
| Access | Single sign-on, multi-factor login, least-privilege roles | DSPT, ISO 27001, DTAC |
| Logging | Every action logged where nobody can edit or delete it | Audit trails, incident investigation |
| Data residency | Locked to UK or EU regions | UK GDPR, NHS expectations |
| Releases | Every change approved before it goes live | IEC 62304, ISO 13485 |
AWS UK and EU regions first; Azure follows.
A quality system built for your product, nothing extra
Arithmia Platform · QMS portal
Tell us what your product does, where you sell it and what data it handles. We pick the rules it must meet and switch on only the modules they need.
We pick the rules that apply
Diagnosis, therapy and wellness products need different things. You see each rule that applies, why, and how ready you are for audit.
Your portal, with only the modules you need
Each rule switches on its modules, from document control to complaints and post-market surveillance. The rest stay off, so audits cover only what applies.
You own your quality system. The portal comes with starter procedures; your people adapt and approve them.
Proof you're compliant, every day
Arithmia Check
Connects read-only to your cloud account, checks every control daily and files the evidence. Nothing to move.
The rules you need
Evidence an auditor trusts
Every result is sealed and linked to the one before, so nobody can alter it.
When a check fails
You get the reason and the fix, ready to apply.
Three ways in
Already on AWS
We add Foundation to your account and connect Check. Your data never moves.
About CheckSet-up isn't compliant
Check shows the gaps; we move your app onto Foundation in your account.
Move your appFind out what your product needs
A fixed-price readiness assessment, with your cloud architecture: £4,950 for a wellness app, £8,500 for software as a medical device, £12,500 for a medical device.