4 documents tagués avec "Regulatory"

Automated inflammatory lesion counting, spatial density measurement, and IGA scoring for acne clinical trials. AI-powered endpoints aligned with FDA guidance.

Automated SALT scoring for alopecia clinical trials. AI-powered measurement of scalp hair loss across the four SALT quadrants from standardised photographs. CE-marked medical device.

ISO 13485 certified, ISO 27001 compliant, GDPR, HIPAA, and 21 CFR Part 11. Audit trails, EU data residency, model version locking, and GCP compliance for clinical trials.

Standardised steps for site staff to place calibration markers and capture lesion photographs, with a do and do-not checklist, how the number of detected markers is reported back, the printable one-page capture guide issued per project, correct and incorrect placement examples by condition, troubleshooting, and storage guidance.