How did BugSense reach certification readiness 75% faster?

CertHub's platform was configured for BugSense's specific IVD device type before documentation work started. In week two, BugSense completed a Regulatory DeepDive with CertHub's IVD Expert Dr. Sebastian Grömminger and regulatory specialist Tayis Arslan, and the IVDR pathway was defined within days. The AI Auto-Extractor converted existing clinical studies into structured product files automatically. QMS setup ran concurrently with documentation, so neither phase waited for the other to finish. That combination produced the 75% time reduction.

BugSense started with academic research data. How did that become regulatory documentation?

CertHub's DxTech framework maps existing research data to the documentation sections required under IVDR. BugSense's clinical studies from TU Munich covered most of the technical file requirements. The AI Auto-Extractor processed each study, matched it to the relevant section, and flagged what was still missing. The team addressed only the gaps, which cut the documentation workload significantly.

The standard QMS timeline is 16 weeks. How did BugSense complete it in 4?

Two factors shortened the timeline. CertHub's process templates provided the SOP structure pre-built for IVD devices, so BugSense defined the content within an existing framework. The Regulatory DeepDive in week two had also established exactly which processes applied to their device, so the team built only the SOPs they needed. Combined, that brought the total to 4 weeks against a typical 16.

Is the Fast Track to CE suitable for an academic spinoff or pre-revenue startup?

The Fast Track to CE is built for teams starting regulatory compliance from zero. BugSense entered the program with feasibility data from TU Munich and no regulatory documentation. By week four, the QMS was complete and technical documentation was underway. The program covers IVDR pathway definition, technical documentation structure, and QMS setup in a single workflow.

What does the regulatory cost saving of up to €205K represent?

The €205K figure represents the estimated cost of achieving the same regulatory output through traditional consulting, billed at standard consultant rates. CertHub delivers the same scope at a fixed subscription cost. The "up to" qualifier reflects variation in consultant pricing and project scope.

BugSense: ISO 13485 QMS in 4 Weeks with CertHub

Questions about Fast Track to Certification for IVD startups

What founders and QM leads ask before starting IVDR compliance with CertHub.