fda-qsr-audit-prep
alirezarezvani/claude-skills
A comprehensive simulation tool designed to pressure-test medical device manufacturers' Quality System Regulation (QSR) compliance against FDA standards (21 CFR 820). It covers six critical areas: complaint handling, process validation, device history records (DHRs), CAPAs, labeling, and handling of Form 483 observations. Essential for pre-inspection readiness, internal audits, and regulatory submission planning.
