Skill UI

This guide defines the role and responsibilities of a Senior Quality Manager Responsible Person (QMR) for highly regulated MedTech and HealthTech environments. It covers essential functions under ISO 13485, including leading management reviews, establishing quality objectives, monitoring performance KPIs, and maintaining strict regulatory compliance oversight. Use this resource when developing a Quality Management System (QMS) or managing regulatory accountability.

This framework provides a comprehensive solution for tracking vulnerability aging and measuring remediation performance against defined Service Level Agreements (SLAs). It helps organizations enforce severity-based timelines, calculate key performance indicators (KPIs) like Mean Time to Remediate (MTTR), and automate escalation procedures to ensure continuous compliance and improve overall security posture.