The Backstory

Smplicare faced a critical DTAC deadline with limited internal capacity and growing concerns around Clinical Safety. With their product close to launch, they needed to address safety requirements quickly and confidently — without slowing product development. Combining the Squirrel™ automated compliance platform and Acorn Compliance’s clinical safety expertise, they met their deadline while dramatically reducing compliance effort.

About Smplicare

Smplicare is a digital health innovation providing personalised exercises and fall risk insights for older adults to support aging well at home. By developing a proactive tool for fall prevention, they improve user independence and provide actionable insights for providers.

The Challenge: Climbing the documentation mountain with a looming deadline

For many healthtech founders, the path to become compliant is blocked by a complex web of overlapping standards. Smplicare realised the amount of requirements mixed with tackling Clinical Safety was leading them to serious compliance anxiety.

They faced three primary hurdles:

• Framework Overwhelm: Navigating the simultaneous requirements of  DTAC, DSPT, Clinical Safety, and International Frameworks without a dedicated compliance manager.
• Clinical Safety Anxiety: Facing the implications of clinical safety on the product led to hesitation around next steps.
• Looming Deadlines: Needing to be compliant by Autumn of 2025 for an essential deal they had in the pipeline with zero room for trial and error. Time was of the essence.

The Solution: Consolidating Overlapping Requirements with a Single Compliance Platform 

While clinical safety provided the ethical and regulatory foundation, Squirrel™ addressed infrastructure and expansion:

• Squirrel™ Pro: Replaced fragmented spreadsheets with a centralised platform for managing DTAC and DSPT requirements.
• Procurement Agility: In due course, the organisation needed to meet an additional compliance standard. Instead of starting from scratch, Squirrel™ duplicated necessary documentation, eliminating redundancy and messy spreadsheets while saving time.
• CSO as a Service: Acorn’s expert Clinical Safety Officer (CSO) stepped in to provide reassurance and advocacy for user safety without stifling innovation
• Warranty Relief: Worries were put at ease knowing that their compliance journey was ensured to end in success. 

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The Results

By using the Squirrel™ platform’s organised system, Smplicare avoided the need for a full-time compliance manager.

• Resource Saving: Using Squirrel™ reduced compliance workload on their team operation by 75%.
• Organised Document Management: The all-in-one system stored and organised compliance documents in a single, auditable location, simultaneously applied across multiple regulatory frameworks with ease. 
• Streamlined Timeline: With a clear and actionable roadmap, Smplicare met their deadline for compliance, ensuring their first deals would be a success.

Client Testimonial

"I didn’t expect to get everything in one place. Not only did we get the guidance on what was needed, but we got the actual help with drafting the documentation. That 'full-service' aspect was the real game-changer for us."

— Alex Melling,  Chief Operations Officer & CoFounder, Smplicare

Take the Stress Out of Compliance

Navigating national and international compliance shouldn’t drain your resources or distract you from your product. Whether you are a founder or a compliance leader tackling DTAC, DSPT or Clinical Safety, we can help you cut your compliance time and costs in half.

Book a Discovery Call Let’s discuss your current compliance roadmap and how Squirrel™ can accelerate your journey across every framework.

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