# Skills tagged "ISO 14971"

3 skills with this tag.

URL: https://rakenne.app/skill-tags/iso-14971/index.md

- [Design Dossier Elaborator](https://rakenne.app/skills/design-dossier-elaborator/index.md) — 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), …
- [ISO 14971 Risk File Author](https://rakenne.app/skills/iso14971-risk-file-author/index.md) — 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 …
- [MDevSPICE Software Risk Management Process](https://rakenne.app/skills/mdevspice-software-risk-management/index.md) — 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.

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