Qms Audit Expert

For medical device companies running ISO 13485 compliance, this handles the full audit lifecycle from risk-based planning through CAPA verification. It knows how to structure internal audit programs, prepare your team for regulatory inspections and certification body visits, and classify findings as major nonconformities versus observations. The process-based auditing approach is solid, covering everything from design controls to post-market surveillance. Most useful when you need to build an audit schedule that actually reflects your risk profile or when you're prepping for an FDA inspection and want to run a realistic mock audit first.