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Your medical device's path to market, made simpler.
Managed in Squirrel™, assured by MDR experts.
Squirrel™ helps you classify your device, build MDR-ready technical files, and keep them aligned with ISO 13485, DTAC and the NHS frameworks you'll need next. Built with MDR specialists, with every output assured by our in-house team and backed by our Compliance Warranty.
• Trusted by the World's Leading Healthtech Innovators •
UK medical device regulation, made practical for health innovators.
Centralised Technical File Management
Technical files that hold up to scrutiny.
Squirrel™ helps you build and maintain MDR-ready technical files for Class IIa and IIb software, keeping your evidence connected across design, risk, verification, validation, and post-market surveillance as your product changes.
Medical Device Expertise
Expert MDR guidance, built in.
Work with our MDR specialists, who review your documentation, run your internal audit, and flag gaps before your Approved Body does. You'll know exactly what's required and have assurance that your file is complete.
Multi-Framework Management
Manage all your frameworks in one place.
Squirrel™ links your MDR files with the standards that sit alongside them, including ISO 13485, ISO 42001 and DTAC, so your safety, quality, and security documentation stays aligned as your software evolves.
Maintain Continuous Compliance
Automation that meets regulatory rigour.
The structure of a platform, the assurance of an MDR specialist. Squirrel™ gives you expert-validated evidence and saves you time, without compromising on the regulatory rigour of your evidence.
AI-powered DTAC guide
Magic away the most boring parts of building a healthtech.
The DTAC Squirrel™ has been built it with 100+ years of combined health-tech expertise. It’s the world’s first AI coach and compliance assistant with embedded DTAC knowledge, built for up & coming innovators like you.
On-demand compliance guidance
Get compliant at the speed of light with our round-the-clock expert help.
Squirrel™ is backed by the world’s most knowledgeable DTAC compliance team. You can access them through Squirrel™ for real-time guidance on all of your compliance and regulatory questions. Save time working out the DTAC mystery and work on what you know best—innovation.
Task management system
Real time compliance notifications and a sleek dashboard to keep you on track.
See simple compliance reports and get notifications that tell you what you need to do, and when you need to do it. Stay organised and hit deadlines with confidence.
DTAC coaching
Invest in continuous compliance, not one-off solutions.
Compliance is not a once and done exercise. You need to level up with every single product release to remain DTAC compliant. That’s why the Squirrel™ is built to help you understand and bake compliance processes into your company culture.
MDR Support that goes
(not 20%, not 50%, not even 80%) 100% of the way.
Support that goes (not 20%, not 50%, not even 80%) 100% of the way.
Built For Health
Designed for digital-health and AI-driven medical devices up to Class IIb. Squirrel™ helps you structure your technical file while linking it to related standards like ISO 13485, DTAC, DSPT and ISO 42001.
End Compliance Silos
Avoid the chaos of scattered frameworks. Squirrel™ connects your MDR evidence to the other standards you'll need, including DTAC, ISO 27001, and ISO 42001, so your security, safety, and privacy work lives in one place.
Powerful Automation
Get the speed of a platform with the assurance of expert oversight. Tasking and reminders keep your file moving while our MDR specialists review every section for accuracy, consistency, and readiness.
Human-in-the-Loop Assurance
Everything created in Squirrel™ is reviewed by our experts. From internal audits to risk reviews, they make sure your documentation is sound before it reaches your Approved Body.
Expert Guidance, On Demand
Need more than MDR support? Tap into Acorn's wider network of specialists, from virtual CSOs and DPOs to penetration testers and UK Responsible Persons, all available through Acorn and Squirrel™. One platform, every expert you need.
Compliance made easy, clients left beaming.
Discover how companies like yours have automated compliance, unlocked new markets, and ditched the compliance chaos.
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The right plan for every stage of your compliance journey.
Start with what you need today and scale to what tomorrow demands.
Join hundreds of digital health innovators simplifying compliance with Squirrel™ 2.0
Starter Plan
£249
Standard Plan
£370
Pro Plan
£970
Starter Plan
£2,499
Standard Plan
£3,996
Pro Plan
£10,476
With every package you have the option to purchase add on services as needed:
You crave the thrill of manual work.
Automating your evidence generation with Squirrel™ might free up too much time for innovation (yikes!).
You enjoy navigating complexity.
Our clear step-by-step guidance might make compliance too easy and understandable (the struggle is real!).
Deadlines are your motivator.
Squirrel™ helps you meet deadlines with ease, potentially eliminating that last-minute scramble some find so invigorating.
You could get compliance assistance from a number of places.
Compliance consultancies
Will reduce some barriers to market and give you expert guidance on your regulatory pathway…
But
They’re expensive and leave you with static evidence that goes out of date when your processes evolve.
Other compliance platforms
Will simplify the work and save you time with self-serve tooling...
But
The accountability stays with you. If your evidence gets challenged, you're the one carrying the risk.
Reasons Squirrel™ is the best of both worlds:
The support of a consulting company. The efficiency of a compliance platform. Better than both.
And we warranty all of your evidence, meaning...
Have questions?
Is my software even a medical device?
UKCA or CE, which do I need?
Is a 12 month contract mandatory?
I'm stuck halfway through and have deadlines approaching. Can you help?
My product is a medical device - can you help?
My product is a medical device — can you help?
What if regulations change while I’m still developing?
No more compliance delays.
Get your device ready for market with experts beside you.
Let Squirrel™ and our specialists handle the heavy lifting on your MDR journey. Book a call and we'll show you how.
