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: device classification, risk summary (ISO 14971:2019), essential principles (GSPR), labelling/IFU, clinical evaluation, post-market surveillance, and traceability per EU MDR 2017/745 Annex II and FDA QMSR (21 CFR Part 4).
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.