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: 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
Learn MoreISO 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.