Skill UI

Provides FDA regulatory guidance for medical device manufacturers encompassing pathway strategy for 510(k)/PMA/De Novo submissions, QSR compliance, HIPAA assessments, and cybersecurity planning to support premarket filings.

A comprehensive tool designed to pressure-test US medical device Quality System Regulation (QSR) compliance (21 CFR 820). It generates a readiness report by interrogating six critical areas—including complaints, CAPAs, and process validation—essential for internal audits, pre-FDA inspections, or responding to Form 483 observations. It ensures alignment with both FDA requirements and ISO 13485 standards.

A rigorous simulation tool for auditing a medical device's Quality Management System (QMS) against ISO 13485 standards. It forces checks on six critical areas: Design History Files (DHF), CAPA effectiveness, Process Validation, Risk Management, Post-Market Surveillance, and Management Review. Essential for pre-audit, MDR, and FDA QSR alignment.