Urikon advances urine diagnostics with a patented sample collection system that stabilizes cells in urine specimen for up to 6 days, enabling accurate diagnostic analysis even with extended transport times. This innovative Class A in vitro diagnostic specimen receptacle device addresses a critical gap in medical diagnostics, as patients as of now have to travel to specialized laboratories to provide a fresh urine sample. The newly developed device will overcome this by a validated sampling and transport procedure. Starting with only a product idea and initial research data, the Urikon team partnered with CertHub's Fast Track to Certification program to transform their innovation into a regulatory-compliant medical device through the systematic Road to Success approach.
Founded by three healthcare and biotechnology experts, Urikon combines deep clinical expertise with cutting-edge biotechnology. The founding team consists of 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), who brings extensive experience in biotechnology production and manufacturing. The team translated a patented stabilizing technology into a product that enables extended urine sample preservation for corresponding analytical methods. Their innovation is particularly valuable when immediate laboratory analysis is needed.
From Innovation to Regulation - The Classic Startup Dilemma
Like many innovative MedTech startups, Urikon had brilliant science and a clear market need but faced the daunting transition from laboratory innovation to regulatory compliance. They had proven feasibility data and research results but no roadmap for transforming their breakthrough into a CE-marked medical device.
Regulatory Knowledge Gap
Despite their extensive medical and scientific expertise, the team lacked specific knowledge of IVDR requirements, technical documentation standards, and quality management systems. They knew their technology worked but didn't know how to prove compliance to regulations and to regulatory authorities.
Resource and Time Constraints
As a three-person startup, Urikon needed to move quickly to market while maintaining focus on their core innovation. Traditional regulatory consulting approaches would have required substantial time and financial resources that could delay their competitive advantage.
Documentation Strategy Uncertainty
The team faced the classic startup challenge: where to begin with regulatory documentation? They had research data, patent applications, and analytical methods but no systematic approach to building IVDR-compliant technical documentation.
Phase 1: Device Configuration and Strategic Clarity
CertHub's Certification Assistant supported by the Onboarding procedure guided Urikon through systematic device characterization, clearly identifying their product as a Class A IVD device and configuring the appropriate regulatory pathway. Within the first week, the team had complete clarity on IVDR requirements and a structured approach to compliance.
Phase 2: Systematic Documentation Development
Using CertHub's DxTech framework, Urikon began systematically transforming their research data into regulatory-compliant technical documentation and building up the Quality Management System. The platform's knowledge units provided clear structure for organizing their device details and available data, while identifying documentation gaps that needed to be addressed.
Phase 3: Quality Management Integration
Parallel to technical documentation, CertHub's BPMN-based Process framework and the AI Auto-Extractor enabled Urikon to build their SOPs from the ground up. The turtle model-based SOPs provided clear processes with defined inputs, outputs, and responsibilities - essential for a growing startup. The Urikon team was impressed how well it worked and how fast they were able to create ISO 13485 compliant SOPs
Phase 4: Current Progress - Rapid Implementation
After just 4 weeks with CertHub, Urikon is making remarkable progress in building their product file and establishing their quality management system. The team has gained complete clarity on their regulatory strategy and is implementing documentation at an impressive pace.
Founded by three healthcare and biotechnology experts, Urikon combines deep clinical expertise with cutting-edge biotechnology. The founding team consists of 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), who brings extensive experience in biotechnology production and manufacturing. The team translated a patented stabilizing technology into a product that enables extended urine sample preservation for corresponding analytical methods. Their innovation is particularly valuable when immediate laboratory analysis is needed.
From Innovation to Regulation - The Classic Startup Dilemma
Like many innovative MedTech startups, Urikon had brilliant science and a clear market need but faced the daunting transition from laboratory innovation to regulatory compliance. They had proven feasibility data and research results but no roadmap for transforming their breakthrough into a CE-marked medical device.
Regulatory Knowledge Gap
Despite their extensive medical and scientific expertise, the team lacked specific knowledge of IVDR requirements, technical documentation standards, and quality management systems. They knew their technology worked but didn't know how to prove compliance to regulations and to regulatory authorities.
Resource and Time Constraints
As a three-person startup, Urikon needed to move quickly to market while maintaining focus on their core innovation. Traditional regulatory consulting approaches would have required substantial time and financial resources that could delay their competitive advantage.
Documentation Strategy Uncertainty
The team faced the classic startup challenge: where to begin with regulatory documentation? They had research data, patent applications, and analytical methods but no systematic approach to building IVDR-compliant technical documentation.
Phase 1: Device Configuration and Strategic Clarity
CertHub's Certification Assistant supported by the Onboarding procedure guided Urikon through systematic device characterization, clearly identifying their product as a Class A IVD device and configuring the appropriate regulatory pathway. Within the first week, the team had complete clarity on IVDR requirements and a structured approach to compliance.
Phase 2: Systematic Documentation Development
Using CertHub's DxTech framework, Urikon began systematically transforming their research data into regulatory-compliant technical documentation and building up the Quality Management System. The platform's knowledge units provided clear structure for organizing their device details and available data, while identifying documentation gaps that needed to be addressed.
Phase 3: Quality Management Integration
Parallel to technical documentation, CertHub's BPMN-based Process framework and the AI Auto-Extractor enabled Urikon to build their SOPs from the ground up. The turtle model-based SOPs provided clear processes with defined inputs, outputs, and responsibilities - essential for a growing startup. The Urikon team was impressed how well it worked and how fast they were able to create ISO 13485 compliant SOPs
Phase 4: Current Progress - Rapid Implementation
After just 4 weeks with CertHub, Urikon is making remarkable progress in building their product file and establishing their quality management system. The team has gained complete clarity on their regulatory strategy and is implementing documentation at an impressive pace.
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."
CertHub's Road to Success eliminated the typical startup confusion about regulatory requirements, providing Urikon with immediate clarity on their IVDR pathway and enabling focused execution from the beginning.
In just 4 weeks, Urikon has made extraordinary progress in building their product file and quality management system, demonstrating how CertHub's structured approach accelerates the innovation-to-regulation transition.
The Fast Track to Certification program is specifically designed for resource-constrained startups, providing enterprise-level regulatory capability without the traditional consulting overhead and timeline.
Urikon's journey demonstrates that even startups with just a product idea and initial research data can quickly establish a professional regulatory pathway using CertHub's systematic approach.
This case proves that CertHub's Fast Track system works effectively for in-vitro diagnostics, addressing the specific challenges IVD startups face in navigating IVDR requirements and building compliant technical documentation.
By building proper documentation and quality systems from the start, Urikon is establishing a foundation that will support their growth, additional product development, and expansion into international markets.
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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