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Why We Built Regtech?

Compliance isn’t just a checkbox. It’s your reputation, your license to operate your legacy.

We didn’t build Regtech to be just another QMS tool. We built it because we’ve lived the stress, the errors, the spreadsheets, and we knew there had to be a better way. Regtech is our answer: a system that thinks like an auditor, adapts like a consultant, and empowers teams to own their compliance.

“We saw brilliant teams lose sleep over paperwork. So we built a system that does the thinking for them.”

Regtech — Not Just a Tool. A Compliance Mindset.

Founded in

0

Location

Porto

Colleagues

0

Revenue generated

$0M

Meet Our Team

Our leaders

We’re 120+ individuals from across the world driven by bold ideas
David Carter

CEO & Founder

Sarah Thompson

CMO & Co-founder

Elementra

Inside Our Agency

What our team has to say about working here

Regtech features

Designed with Empathy, Not Just Efficiency

Minimalist layouts to reduce screen clutter
Auto-logic that applies document prefixes, populates procedures, and alerts you to risks
Mobile-first design, so you can review, approve, or track tasks — wherever you are
Our Guiding Principle

The 3Ps of Compliance

People

Role-based dashboards and task alerts keep your team aligned

Process

Structured workflows ensure consistency and accountability

Proof

Time-stamped audit trails and secure records seal your compliance

Our Guiding Principle

The 3Ps of Compliance

We believe every effective QMS rests on People, Process, and Proof.
And Regtech is purpose-built to align all three

People

Role-based dashboards and task alerts keep your team aligned

Process

Structured workflows ensure consistency and accountability

Proof

Time-stamped audit trails and secure records seal your compliance

These aren’t just principles — they’re product features.

What Drives Us

To make regulatory excellence accessible, intelligent, and audit-proof.

Mission:
To redefine quality management for medtech — by creating a compliance platform so intuitive, it feels invisible.

Vision: 
To make Regtech the default operating system for quality in every medical device company — seamlessly embedded, empowering, and essential. Not a tool, but a standard.

Join Our Journey

Core Values

Compliance First, Always

We are built from the regulations up. Every feature we develop aligns with real-world standards.

Empathy in Every Interaction

We design for the people behind the process. From intuitive UI to guided onboarding, we ensure Regtech feels natural, not forced, for every RA/QA, every manager, and every trainee.

Simplicity with Substance

We believe quality systems should be clean, not cluttered. Our workflows are minimal by design, yet powerful under the hood. Because compliance shouldn’t come at the cost of clarity.

Proof Over Promises

We are built from the regulations up. We don’t just track data, we secure it, timestamp it, and make it audit-ready. Every action in Regtech leaves behind the traceability you can trust.

Built for Scale, Backed by Experts

Regtech isn’t just software, it’s years of regulatory consulting, embedded in code. We grow with you, from startup pilots to enterprise rollouts.

We Make Quality Feel Effortless

Because when compliance blends into how your team works, it becomes a strength, not a struggle.

Join Our Journey

Core Values

icon_1-removebg-preview

Compliance First, Always

We are built from the regulations up. Every feature we develop aligns with real-world standards.

icon_2-removebg-preview

Empathy in Every Interaction

We design for the people behind the process. From intuitive UI to guided onboarding, we ensure Regtech feels natural, not forced, for every RA/QA, every manager, and every trainee.

icon_3-removebg-preview

Simplicity with Substance

We believe quality systems should be clean, not cluttered. Our workflows are minimal by design, yet powerful under the hood. Because compliance shouldn’t come at the cost of clarity.

icon_4-removebg-preview

Proof Over Promises

We are built from the regulations up. We don’t just track data, we secure it, timestamp it, and make it audit-ready. Every action in Regtech leaves behind the traceability you can trust.

icon_5-removebg-preview

Compliance First, Always

Regtech isn’t just software, it’s years of regulatory consulting, embedded in code. We grow with you, from startup pilots to enterprise rollouts.

ChatGPT_Image_Aug_1__2025__12_42_34_PM__1_-removebg-preview

We Make Quality Feel Effortless

Because when compliance blends into how your team works, it becomes a strength, not a struggle.