Success story · Startup

From research data to regulatory pathway. In 4 weeks.

Urikon had a patented urine diagnostic device, feasibility data, and no regulatory roadmap. In 4 weeks with CertHub, the team had a structured IVDR pathway, compliant technical documentation in progress, and a working QMS foundation.

IVDR pathway defined in week one

Class A IVD · Urine Diagnostics · IVDR

About Urikon

A diagnostic startup solving a real gap in patient care

Urikon is developing a specimen collection device that stabilizes urine cells for up to 6 days. Today, patients needing urine diagnostics have to deliver fresh samples directly to specialized laboratories. Urikon's system changes that: samples can be collected at home and transported without losing diagnostic accuracy.

The company was founded by Dr. Simon Ronicke (Intensive Care Physician and CEO), Dr. Philipp Enghard (Nephrologist and Senior Consultant at Charité Berlin), and Anton S. Khartulyari (CEO of Genosynth GmbH). Together, they translated a patented stabilizing technology into a Class A IVD device targeting CE marking under IVDR.

Industry

IVD Diagnostics

Headquarters

Germany

Device class

Class A IVD

Regulation

IVDR

The challenge

Regulatory compliance was entirely new territory for the team.

Urikon had research data, a patent, and a clear market need. What they didn't have was a roadmap from lab innovation to CE-marked medical device. IVDR requirements, technical documentation standards, and QMS structure were all new territory for the team.

Before CertHub

No roadmap from product idea to IVDR compliance.

No knowledge of IVDR technical documentation requirements.

QMS starting from zero, no existing structure.

Risk of spending time and money on the wrong regulatory approach.

With CertHub

Class A IVD classification and IVDR pathway confirmed in week one.

Research data structured into compliant technical documentation.

ISO 13485-compliant SOPs built from scratch in the platform.

Clear compliance plan before building any documentation.

How CertHub helped

From research data to compliant documentation.

CertHub's Road to Success program gave Urikon a structured path from product idea to regulatory compliance. The team didn't have to determine the documentation order or QMS structure on their own. The program is built for startups: it provides regulatory guidance, documentation templates, and QMS structure in a single workflow.

Defined the regulatory pathway

CertHub's onboarding identified the device as a Class A IVD and confirmed the IVDR requirements in week one. The team had a clear compliance plan before building any documentation.

Converted research into documentation

Using CertHub's DxTech framework, Urikon's existing research data was structured into IVDR-compliant technical documentation. The platform showed exactly what was complete and what was missing.

Built the QMS from scratch

CertHub's process framework and AI Auto-Extractor enabled Urikon to create ISO 13485-compliant SOPs, each with defined inputs, outputs, and responsibilities.

The result

In 4 weeks, Urikon went from a product idea to a structured IVDR pathway, compliant documentation in progress, and a functioning QMS foundation. That structure covers new products and markets as the company expands.

week to full IVDR regulatory clarity

weeks to QMS foundation and compliant technical documentation

Dr. Simon Ronicke

CEO, Urikon

CertHub solved our biggest challenge — we knew our technology was revolutionary, but we didn't know how to navigate the regulatory maze. The Road to Success gave us a clear, systematic approach from day one.

Get your IVDR pathway in week one.

Urikon went from product idea to structured regulatory compliance in 4 weeks. See how the Fast Track to CE works.

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Questions about IVDR compliance for IVD startups

How quickly can a first-time IVD startup get regulatory clarity?

We have research data but no regulatory documentation. Where do we start?

How does CertHub help build a QMS from scratch for an IVD startup?

Does CertHub work for Class A IVD devices, or only more complex device classes?

What's the difference between CertHub and hiring a regulatory consultant?