ISO 13485
Skill packages tagged with “ISO 13485”
CAPA Report
Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485).
Design Dossier Elaborator
Guided elaboration of design dossier, technical file, or device master record sections for medical devices: risk summary, essential principles (GSPR), labelling, and traceability to risk file and standards per MDR Annex II/III and FDA design control.
QMS CAPA Tracker
Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces Effectiveness Check completeness, and validates CAPA structure against ISO 13485 and FDA 21 CFR Part 820 requirements.