IVD Analyzer Group

A multi-language EU tender spanning four jurisdictions — France, Germany, Spain, and Italy — with conflicting MDR/IVDR requirements. Each jurisdiction required different evidence formats and regulatory documentation.

Previous tools couldn’t handle cross-border compliance mapping. The team was manually reconciling regulatory timelines across jurisdictions, risking disqualification from timing conflicts they couldn’t easily detect.

MedStrato resolved cross-border compliance gaps automatically, generated jurisdiction-specific evidence packs, and produced a unified submission in three languages at full parity.

Regulatory cross-checks caught two MDR timing conflicts before submission — issues that would have led to disqualification in the French and German jurisdictions.