Qnomx Gains Regulatory Clarity with a Fractional Expert on Their Team
Qnomx went from regulatory uncertainty to building a clear, actionable pathway toward certification - supported by hands-on quality system setup and expert guidance.
Qnomx is a SaMD company developing an AI-based platform for interpreting cancer genomics profiles.
Their mission is to empower clinical laboratories and hospital providers around the world with actionable genomic insights.
As a healthtech startup operating in a highly regulated space, Qnomx needed expert support to define and implement the right quality and regulatory framework for their product.
Before
After
“What we really like working with you is that it’s both high‒level guidance as well as hands‒on support and delivery where it’s needed… You’re working like an embedded team member - like our fractional regulatory expert.” – Jörg Hölzing, Co-founder & Co-CEO, Qnomx
The Process
Conducted a high-level regulatory assessment workshop to identify the most appropriate certification path.
Delivered detailed recommendations on QMS setup and documentation structure.
Reviewed and refined intended use statements and technical file planning.
Supported selection and early engagement with notified bodies.
Provided ongoing support and feedback as a hands-on, fractional team member.
By partnering with Evoleen Access, Qnomx was able to turn regulatory ambiguity into a well‒defined and actionable roadmap. With the foundation for a scalable QMS in place and expert support on call, the team is now confidently progressing toward certification - ready to bring their cancer genomics platform to global markets.
Read More Case Studies
