Device safety & performance data
Data collection structured around device-specific endpoints, including technical/procedural success, device deficiencies and malfunctions, and adverse events attributable to device versus procedure.
Why device sponsors choose us
Built for FDA and EU MDR/IVDR evidence packages
Three ways an integrated Biometrics and Clinical Operations model changes how a device program runs.
Evidence generation for FDA & MDR/IVDR
Clinical operations and biostatistics support for pivotal IDE studies and EU MDR/IVDR clinical evaluation, including post-market clinical follow-up designs for CE-marked devices.
Operator & learning-curve effects
Analysis approaches that account for operator experience and learning-curve effects in device performance data, keeping pivotal results defensible under regulatory review.
Common questions
Before you scope a device study
Running a device or combination product program?
Tell us your regulatory pathway and study phase — we'll map a Biometrics and Clinical Operations model built for FDA and EU MDR/IVDR evidence.