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Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
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Reference for querying the Atlas knowledge graph through its MCP tools — the SECONDARY enrichment/comparison layer that adds best-practice context to systems you have ALREADY scanned from your real sources (`az`, repos, dirs). Use when you need to look up nodes, edges, kinds, clusters, stats, or wiki pages in Atlas to compare against your real inventory. (atlas graph, query atlas, atlas mcp, search the graph, graph neighbors, atlas record, atlas kinds, enrichment layer)
Atlas turns your STATED NEED into a real systems atlas by SCANNING your actual sources (Azure via `az`, git repos, local dirs) and process/data mining them, THEN enriching against the Atlas knowledge graph. Use this skill when asked to inventory/map your real systems, scan your cloud + repos + directories, mine the real processes or data they contain, or collect their real constraints/gotchas. (atlas, scan my systems, inventory our azure account, map my repos, real systems atlas, process mining, data mining, collect nuances, system discovery)
This skill should be used when the user asks to "find skills in the wild", "assimilate popular workflows", "discover SKILL.md files in repos", "research external skills", "find workflow patterns", "survey the skill landscape", "what skills exist out there", or wants to investigate public repositories for extractable processes, babysitter plugins, and reusable procedural insights. Searches GitHub for SKILL.md files, classifies repos by archetype, and maintains structured research under docs/reference-repos/.
SKILL.md 표시 중
SOC 직업 분류 기준
| name | iso14971-risk-analyzer |
| description | Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis |
| allowed-tools | ["Read","Write","Glob","Grep","Edit","Bash"] |
| metadata | {"specialization":"biomedical-engineering","domain":"science","category":"Risk Management","skill-id":"BME-SK-008"} |
| graph | {"domains":["domain:biomedical-engineering"],"skillAreas":["skill-area:statistical-analysis","skill-area:data-analysis","skill-area:compliance-automation"],"workflows":["workflow:experiment-design","workflow:peer-review-cycle"],"roles":["role:biomedical-engineer","role:research-engineer"]} |
The ISO 14971 Risk Analyzer Skill implements comprehensive risk management methodology per ISO 14971:2019 for medical devices, supporting hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle.
This skill integrates with the following processes:
iso14971-risk-analyzer:
risk-categories:
- clinical
- electrical
- mechanical
- software
- biocompatibility
- sterility
- usability
probability-levels: 5
severity-levels: 5
acceptability-criteria:
ALARP: true
state-of-art: true