Flinn.ai Reaffirms ISO 27001 Certification: How We Ensure Security in the MedTech Space

At Flinn, we work side by side with companies that operate in one of the most regulated industries in the world: MedTech. That automatically means that data protection, integrity, and confidentiality are their top priorities and as their software partner, we’re held to the same standard.

That’s why we’re proud to announce our ISO 27001 certification! And instead of just celebrating the stamp, we want to take you behind the scenes and share what this milestone really means - not just for us, but most importantly, for our customers!

What Does This Certification Mean?

Let’s start with the most obvious question: what is ISO 27001? It’s one of the most recognized international standards for information security. And for good reason: it requires organizations to establish a robust Information Security Management System (ISMS), implement risk-based controls, and regularly prove they’re doing what they claim.

For Flinn, this certification aligns perfectly with one of our core values: integrity. It ensures that everything we do, from how we develop software to how we manage data, is built on a foundation of transparency, structure, and security.

So, First Things First: What Changes for Our Users?

In short: more trust, less uncertainty. The ISO 27001 audit process is external and independent. It validates that we handle your data responsibly, and that our internal processes can withstand scrutiny. Especially for users working with sensitive clinical or regulatory data, this added layer of assurance is key.

And What’s Changed Internally?

1. A Clearer View of Tools and Access: Like most SaaS companies, we rely on a variety of tools and development systems. The difference? Ours are now fully documented, assessed for risk, and tied to clear access and management responsibilities.
   This level of structure means that in the event of an incident or audit, we know exactly where to look and what to do!

2. Security by Design, Not by Default: At Flinn, our development processes prioritize security from day one. We know that rushing ahead and patching later is risky, so we’ve flipped the script. The result: better oversight, stronger data integrity, and less technical debt.

3. Roles and Responsibility: Robin, our Chief Information Security Officer (CISO), oversees ISO 27001 as part of his role. He also bridges compliance efforts across GDPR, risk management, and development standards. At Flinn, we don’t think in silos. We take an interdisciplinary approach, which allows us to implement standards more efficiently and in a way that truly fits our workflows and culture.

4. 100% Cloud-Based and Paperless: Our Information Security Management System (ISMS) lives now entirely in the cloud: no USB drives, no hard copies - everything is stored securely in the cloud, not on local devices. This approach reduces both security risks and complexity. Everything from reviews to role management and access tracking happens within a single digital system.

All of this comes together in our integrated security model, led by our CISO and built on the intersection of ISO 27001, risk management, and secure software development:

Challenges and Learnings

Our ISO 27001 audit resulted in zero non-conformities (a result we’re proud of!).But trust us when we say that we put a lot of effort in getting there and ensuring compliance!

The biggest? Complexity. We operate across many tools and interfaces, and structuring all of that into an auditable, transparent system took precision and focus. What truly made the difference was our team’s early awareness and openness toward the topic, paired with the commitment to see it through. Security has always been a shared priority at Flinn, and that collective mindset was essential.

Our CISO, Robin, also shared a personal takeaway:

While I expected the external audit to be tough, it turned out to be a thoroughly collaborative and constructive experience. The auditors were solution-oriented and pragmatic, which made the entire process not just effective, but genuinely positive. Tools like Vanta were also instrumental. Their platform helped us automate many recurring tasks, saving time and reducing human error.

And here’s a bonus insight: At Flinn we run annual security tests such as penetration tests with external security experts. These “ethical hackers” try to break into our systems and help ensure that our defenses are not just theoretical, but battle-tested. The results of our latest “professional hacker attack” confirmed that our defenses are on solid ground!

Looking Ahead!

Our ISMS isn’t a one-time project, it’s a living system, designed to grow with us. As we scale, we’ll continue investing in regular trainings, clear responsibilities, and a systematic approach to information security.

After receiving our initial certification last year, we now successfully completed our re-certification with zero non-conformities. That’s proof not just of compliance, but of consistency!

Curious to Learn More?

If you'd like to hear how we implemented our ISMS or see how we handle compliance and data protection in practice, we’re happy to set up a call. And if you're interested, we can also provide our ISO 27001 certificate upon request. Just reach out - we'd be happy to talk.