After QMSR: what FDA investigators will look for, and how to prepare your post-market team now

Free On-Demand Webinar

With the FDA’s QMSR aligning more closely to ISO 13485, medical device companies face a new era of inspection expectations. Post-market teams will be under fresh scrutiny as regulators look deeper into complaint handling, CAPA, MDR, and risk management systems.

Key learnings:

• What FDA auditors will prioritize under QMSR and how post-market teams can prepare now

• Practical steps to strengthen processes, tighten traceability, and build confidence before inspectors arrive

• How modern eQMS tools, like Greenlight Guru Ultralight, help teams operationalize compliance and stay inspection-ready without adding complexity.