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

Urikon had complete clarity on their IVDR requirements and device classification within the first week. The Road to Success program starts with systematic device characterization: identifying the device class, applicable standards, and documentation scope before any documentation work begins.

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

With what you have. Urikon came to CertHub with a patent, feasibility data, and no regulatory structure. CertHub's DxTech framework identifies which existing data covers which IVDR requirements and which gaps still need to be filled. The platform shows exactly what's complete and what's missing, so the team works in the right order from day one.

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

CertHub's process framework provides BPMN-based SOPs with defined inputs, outputs, and responsibilities for each process. The AI Auto-Extractor converts existing documents into structured, ISO 13485-compliant SOPs automatically. Urikon built their full QMS without starting with an empty template.

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

CertHub supports all IVD device classes under IVDR. For Class A devices like Urikon's, the documentation and QMS requirements are well-defined. The platform configures the regulatory pathway and documentation scope to match the specific class and intended purpose. The team doesn't build documentation they don't need.

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

CertHub gives startups an IVD expert session to define the pathway, then a platform to build everything within. Urikon completed their IVDR pathway, technical documentation, and QMS foundation in 4 weeks. The same work would have taken months with a traditional consulting approach.

IVDR Clarity in 1 Week: Urikon's Path to CE

Questions about IVDR compliance for IVD startups

What founders ask before building their regulatory foundation with CertHub.