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: 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).
Medical Devices
ISO 13485
EU MDR
FDA
Technical Documentation
Compliance
ISO 14971
GSPR
IEC 62304
IEC 62366
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