How Corti supports your medical device compliance

When you’re building healthtech, speed and scale matter, but so does trust. Regulatory compliance is one of the biggest hurdles standing between a promising prototype and a product that can safely reach patients. At Corti, we believe developers shouldn’t have to choose between agility and safety. That’s why we’ve designed our platform, our processes, and our documentation to help you navigate medical device compliance with confidence.

Why compliance matters for builders

Getting to market in the UK and EU requires more than innovative technology. It requires proving - to regulators, auditors, and clinicians - that your product is safe, reliable, and transparent. Without the right partner, this can mean months of delays, costly audits, and uncertainty.

That’s where Corti comes in. Unlike generic model providers, Corti builds its infrastructure for healthcare from the ground up: with compliance as a first-class feature.

Corti’s medical device foundations

Corti Assistant is registered as a Class I medical device in the UK, and we are actively pursuing EU MDR approval. This means our partners inherit a foundation that is already aligned with the strictest regulatory frameworks.

Our models are developed under internationally recognized standards, including:

• ISO 13485 quality management‍
• ISO 14971 risk management‍
• IEC 62304 software lifecycle processes‍
• ISO 62366 Usability engineering
  

These are critical proof points that demonstrate our technology is trustworthy, reliable, and built to withstand scrutiny from regulators and auditors worldwide.

Simplifying ongoing compliance

Compliance doesn’t end at launch. That’s why Corti goes beyond initial approvals:

• Transparent model updates: We carefully control and clearly communicate all model changes, so your compliance stays intact.‍
• Specialist support: We partner with experienced regulatory professionals who can advise and support you.‍
• Audit readiness: On request, we provide technical documentation to you or directly to regulatory agencies and are prepared to be audited as a critical supplier on your behalf.
  

Documentation at your fingertips

When you integrate Corti’s APIs, you also gain access to a comprehensive documentation pack designed to streamline your compliance journey. This includes software architecture, risk management files, clinical evaluation, testing reports, and other MDR-aligned evidence. We also provide an AI impact assessment and documentation that can support with the EU AI Act compliance for a high risk AI product.

In other words, the paperwork that typically slows down is already in your hands.

This is why you cannot easily do it on your own:

To comply with UKCA or EU MDR as a medical device manufacturer, you must build an extensive documentation set from the ground up.

Creating these documents requires deep regulatory experience and a multi-disciplinary team, from QA/RA professionals to clinical writers, software architects, and testing engineers. Some of the most resource-intensive documents that Corti can support you with are:

• Technical performance and architecture — usually requiring several design iterations and reviews‍
• Literature-basedClinical Evaluation Reports — time-consuming and often rejected if not formatted precisely‍
• Hazard log of the Risk Management File (ISO 14971) — must be methodologically sound and integrated with software lifecycles‍
• Validation Testing Reports — require pre-defined protocols, user testing, and statistical analysis

By partnering with Corti, you’ll receive a validated documentation pack covering many of the required components, already aligned with regulatory expectations.

This can save:

• Several weeks of preparation time
• Hundreds of hours of cross-functional effort
• Tens of thousands of euros

Even better, Corti provides ongoing version control to support your compliance.

Ready for new markets

If you’re aiming for approval in a region with unique requirements, we’ll work with you to meet them. Our approach is collaborative: when you succeed, so do we.

Build safer, faster, smarter

With Corti, compliance doesn’t need to be a blocker. By embedding regulatory readiness into our infrastructure, we help you get to market faster - without compromising safety or trust.

Healthtech builders deserve a partner who understands the code, the clinic and the regulation. That’s why we’re here: to make sure your innovation reaches the people who need it most, backed by accuracy, safety, and regulatory confidence.