Medical Devices
Skill packages tagged with “Medical Devices”
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.
ISO 14971 Risk File Author
Guided elaboration of risk management file for medical devices per ISO 14971: hazard identification, risk analysis, risk control, residual risk acceptability, and benefit–risk rationale. Flags risks above acceptability thresholds without control or justification.