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Streamline ISO 13485 compliance
with the platform built for healthtech.
Squirrel™ 2.0 helps health innovators meet ISO 13485 requirements, demonstrate trust to regulators and manage every complimentary framework like DTAC, ISO 27001, SOC 2, and HIPAA, all in one place.
• Trusted by the World's Leading Healthtech Innovators •
The smart path to achieving and maintaining ISO 13485 compliance.
Intelligent Compliance Platform
Centralised ISO 13485 Management.
Bring every design record, risk log, and quality process into one structured platform. Squirrel™ 2.0 helps you build and maintain ISO 13485 compliance with guided workflows, automated reminders, and expert-backed templates.
AI Compliance Copilot
Guided ISO 13485 readiness, built in.
Need help understanding what each requirement means or what to do next? Squirrel™ 2.0’s Compliance Copilot answers your questions, guides you through every clause, and generates the evidence you need, backed by expert support.
Multi-Framework Management
Manage all your frameworks in one place.
Squirrel™ 2.0 connects ISO 13485 with ISO 27001, SOC 2, HIPAA, and DTAC, as well as AIaMD and SaMD requirements, so your evidence and reviews count towards all your frameworks.
Maintain Continuous Compliance
Stay compliant between audits.
ISO 13485 is rarely managed in isolation. Squirrel™ 2.0 helps you maintain continuous compliance across every framework, including DTAC, SaMD and more, so your compliance posture stays up to date.
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.
Streamlined ISO 13485 compliance
for teams that move fast.
Support that goes (not 20%, not 50%, not even 80%) 100% of the way.
Built For Health
Built for teams that understand the strict security and compliance demands of healthcare. Unlike single-framework QMS tools, Squirrel™ 2.0 helps digital health innovators meet ISO 13485 requirements alongside DTAC, HIPAA, and more, all in one connected platform.
End Compliance Silos
Managing multiple frameworks shouldn’t mean repeating work. Squirrel™ 2.0 links tasks, evidence, and reviews across ISO 13485, AIaMD/SaMD, and DTAC so your compliance story stays consistent.
Powerful Automation
Squirrel™ 2.0 automates reminders, version control, and evidence tracking while the AI Copilot guides you through each requirement step-by-step. Together, they remove guesswork, and keep your evidence audit-ready year-round.
Human-in-the-Loop Assurance
Everything generated in Squirrel™ 2.0 is backed by regulatory experts. Our team reviews your evidence, policies, and conducts your internal audit to ensure you’re fully prepared before certification.
Expert Guidance, On Demand
Need additional support? Work directly with Acorn’s consultants inside Squirrel™ 2.0. From SaMD experts to fractional CSOs, our experts can review complex submissions, and provide strategic guidance to strengthen your compliance programme.
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
Can provide guidance and help set up your QMS and documentation...
But
They’re expensive and leave you with static evidence that goes out of date when your processes evolve.
Other compliance platforms
Provide templates and workflows to help you build your ISO 13485 documentation...
But
Most don’t connect DTAC, HIPAA, or SaMD frameworks, or include the expert oversight needed to keep you compliant between audits.
Reasons Squirrel™ 2.0 is the best of both worlds:
As smart as a consulting company. As affordable as a compliance platform. Better than both.
And we warranty all of your evidence, meaning...
Have questions?
I don’t even know where to start!
We’ve already completed DTAC — do we need to pay for it as part of our subscription?
Is a 12 month contract mandatory?
I'm stuck halfway through and have deadlines approaching. Can you help?
Do I need a Clinical Safety Officer?
My product is a medical device — can you help?
What if regulations change while I’m still developing?
No more compliance delays.
Ditch the paperwork and launch lightning-fast.
Let Squirrel™ 2.0 handle compliance for you, 10x faster. Let’s get on a call, and we’ll show you how.
