# Skills tagged "IEC 62304"

11 skills with this tag.

URL: https://rakenne.app/skill-tags/iec-62304/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), …
- [IEC 62304 Software Lifecycle Author](https://rakenne.app/skills/iec62304-software-lifecycle-author/index.md) — Guided elaboration of medical device software lifecycle documentation per IEC 62304 — SDP, SOUP identification, SRS, design, verification/validation, and risk control integration.
- [MDevSPICE Capability Profile](https://rakenne.app/skills/mdevspice-capability-profile/index.md) — Draft a capability profile or assessment pack for MDevSPICE; document target capability levels and evidence per process for assessors.
- [MDevSPICE Process Area Documentation](https://rakenne.app/skills/mdevspice-process-area-documentation/index.md) — Document how each MDevSPICE process area is implemented; create evidence for MDevSPICE assessment and auditors.
- [MDevSPICE Process Coverage](https://rakenne.app/skills/mdevspice-process-coverage/index.md) — Map organizational processes to the MDevSPICE process reference model and IEC 62304; document process coverage for assessment or audit.
- [MDevSPICE Regulatory Readiness Narrative](https://rakenne.app/skills/mdevspice-regulatory-readiness-narrative/index.md) — Draft a regulatory readiness narrative for FDA (21 CFR 820), EU MDR, and IEC 62304; document evidence and alignment for audit or submission.
- [MDevSPICE Software Configuration Management Process](https://rakenne.app/skills/mdevspice-software-configuration-management/index.md) — Document and evidence the software configuration management process per IEC 62304 and MDevSPICE: identification, change control, build and release, configuration status accounting.
- [MDevSPICE Software Development Process](https://rakenne.app/skills/mdevspice-software-development/index.md) — Document and evidence the software development process per IEC 62304 and MDevSPICE: development plan, requirements, design, implementation, verification, integration and system testing, release.
- [MDevSPICE Software Maintenance Process](https://rakenne.app/skills/mdevspice-software-maintenance/index.md) — Document and evidence the software maintenance process per IEC 62304 and MDevSPICE: maintenance plan, problem and modification analysis, implementation of changes, maintenance release, retirement.
- [MDevSPICE Software Problem Resolution Process](https://rakenne.app/skills/mdevspice-software-problem-resolution/index.md) — Document and evidence the software problem resolution process per IEC 62304 and MDevSPICE: problem reporting, analysis, root cause, corrective action, and link to maintenance and CAPA.
- [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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