This skill provides a comprehensive framework for medical device companies to establish, maintain, and audit their Quality Management System (QMS) in accordance with ISO 13485:2016. It offers standardized workflows for document control, CAPA management, internal auditing, and process validation (IQ/OQ/PQ), streamlining the path to certification and ensuring continuous regulatory compliance. It acts as a digital quality specialist, guiding users through gap analysis, supplier qualification, and management review preparation to maintain high standards of product safety and efficacy.
主要功能
01Risk-based supplier qualification and performance monitoring
02Structured internal audit planning and finding classification
03ISO 13485:2016 gap analysis and implementation roadmaps
04Process validation (IQ/OQ/PQ) protocol and report generation
050 GitHub stars
06Automated document control and numbering workflows
