ISO 14971
Skill packages tagged with “ISO 14971”
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).
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.
MDevSPICE Software Risk Management Process
Document and evidence the software risk management process per IEC 62304 and MDevSPICE: risk management plan, risk analysis, risk control, risk review, production and post-production monitoring.