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Manage SaMD, AIaMD, and every compliance framework in one place.
Built with MDR consultants and governance experts, Squirrel™ 2.0 helps you manage technical files, audits, and every other healthtech framework, DTAC, ISO, HIPAA, and beyond, all in one place.
• Trusted by the World's Leading Healthtech Innovators •
Responsible AI and SaMD compliance, made practical for health innovators.
Intelligent Compliance Platform
Centralised Technical File Management.
Squirrel™ 2.0 helps you build and maintain MDR-ready technical files for Class IIa and IIb software, streamlining evidence across design, risk, verification, validation, and post-market activities.
Medical Device Expertise
Expert MDR Guidance, Built In.
Work with our MDR consultant, who will review your documentation, run your internal audit, and flag gaps before the notified-body review. You’ll understand exactly what’s required and have assurance that your file is complete.
Multi-Framework Management
All your frameworks in one place.
Squirrel™ 2.0 links your MDR files with related frameworks like ISO 13485, ISO 42001 and DTAC, ensuring your safety, quality, and security documentation stay aligned as your software evolves.
Maintain Continuous Compliance
Efficiency that meets regulatory rigour.
The structure of a platform. The assurance of an MDR consultant. Squirrel™ 2.0 delivers a cutting edge platform with expert validation, helps you by saving you time without sacrificing rigour.
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 42001 compliance for responsible AI teams.
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™ 2.0 help you structure your technical file while linking seamlessly to related standards like ISO 13485, DTAC, DSPT, ISO 42001 and more.
End Compliance Silos
Avoid the chaos of scattered frameworks. Squirrel™ 2.0 connects your MDR evidence with other key standards such as DTAC, ISO 27001, and ISO 42001, so you can manage your security, safety, and privacy frameworks in one place.
Efficiency & Rigour
Get the speed of a platform with the assurance of expert oversight. Tasking and reminders keep your file moving while our MDR consultants validate every section for accuracy, consistency, and readiness.
Human-in-the-Loop Assurance
Everything created in Squirrel™ 2.0 is reviewed by our governance experts.From internal audits to risk reviews, they’ll ensure your documentation meets regulatory requirements prior to submission.
Expert Guidance, On Demand
Need more than MDR support?Access Acorn’s full network of compliance specialists, from virtual CSOs and DPOs to penetration testers and data-privacy consultants, all available through Acorn and Squirrel™ 2.0. One platform, every expert you need to stay compliant.
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 entry and
provide initial guidance for GDPR...
But
Might not be very start-up friendly, and will definitely cost an arm and a leg.
Other compliance platforms
Will simplify compliance requirements and save you some time...
But
Might not underwrite your compliance evidence to guarantee that you will pass external audits and assessments.
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.
