Implements and maintains ISO 13485 compliant Quality Management Systems for medical device organizations.
This skill provides specialized domain expertise for medical device companies seeking to establish, maintain, or audit an ISO 13485:2016 Quality Management System (QMS). It offers structured workflows for every phase of quality management, from performing initial gap analyses and creating documented procedures to managing Corrective and Preventive Actions (CAPA). Users can leverage this skill to generate document control systems, internal audit schedules, process validation protocols (IQ/OQ/PQ), and supplier qualification matrices, ensuring full regulatory compliance and readiness for certification audits.
주요 기능
01ISO 13485:2016 gap analysis and implementation roadmaps
02Supplier risk assessment and performance monitoring tools
031 GitHub stars
04Process validation frameworks for IQ, OQ, and PQ phases
05Internal audit program planning and auditor qualification guides
06Standardized document control and numbering systems
사용 사례
01Automating the generation of CAPA reports and supplier evaluation records
02Establishing a QMS for a medical device startup from the ground up
03Preparing for ISO 13485 certification or annual surveillance audits
