Technical Documentation
Skill packages tagged with “Technical Documentation”
CE Technical File Author
Guided elaboration of CE technical documentation and Declaration of Conformity (DoC): applicable directives/regulations (e.g. RED, LVD, EMC, MDR, IVDR, Machinery), risk assessment, essential requirements checklist, and DoC content per product.
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.