BC medical-device-cybersecurity
医疗器械网络安全合规实操手册——覆盖全球三大市场监管要求（美国 FDA 2026 网络安全强制：SBOM 软件物料清单/漏洞管理/渗透测试，缺失即不予受理 RTA；欧盟 MDR Annex I 17.2 + NIS2 + Cyber Resilience Act 2027；中国 NMPA 网络安全注册审查指导原则）、SBOM 构建实操（字段/更新/供应链）、漏洞管理与协调披露（CVSS 分级/修复时限）、网络安全体系与文档（ISO/IEC 81001-5-1、与 ISO 13485/62304 联动、上市后监控），含三地要求对照与申报文档清单，附零依赖本地工具一键查询区域要求、生成检查清单与 SBOM 字段模板。面向医械法规、研发与信息安全负责人，与 AI 医疗器械合规互补。
医疗器械网络安全合规实操手册——覆盖全球三大市场监管要求（美国 FDA 2026 网络安全强制：SBOM 软件物料清单/漏洞管理/渗透测试，缺失即不予受理 RTA；欧盟 MDR Annex I 17.2 + NIS2 + Cyber Resilience Act 2027；中国 NMPA…
As a process C 53/100 · Has gaps — weak spots: result and completion, when it triggers, inputs and preconditions
How to improve
- Say in the description WHEN to use the skill ("use when…", example requests): that is the agent's main cue.
- For Hermes the description must be one sentence under 60 characters; move the conditions to a "When to Use" section.
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 1
✓ No critical or high findings
Medium and low: 1
-
low Risky intent
intent-offensive-securitySKILL.md:17Offensive-security / dual-use content (legitimate for authorised testing; review intended use)description_en: A hands-on compliance playbook for medical device cybersecurity — covering global regulatory requirements (US FDA mandatory cybersecurity since 2026: SBOM/vulnerability management/pene
Files scanned: 18. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
frontmatter-yamlSKILL.md: the frontmatter is not valid YAML (YAML parse error: Nested mappings are not allowed in compact mappings at line 16, column 17: description_en: A hands-on compliance playbook for medical device cybersecurity… ^ ); fields were read line by line. The usual cause is a colon inside an unquoted value - warning
description-long-hermesdescription is 342 chars; the Hermes authoring standard requires ≤ 60 (one sentence, ending with a period) - warning
description-no-whenneither description nor a "## When to Use" section says when to use the skill - note
frontmatter-keyunknown frontmatter key "slug" - note
frontmatter-keyunknown frontmatter key "display_name" - note
frontmatter-keyunknown frontmatter key "displayName" - note
frontmatter-keyunknown frontmatter key "title" - note
frontmatter-keyunknown frontmatter key "description_en"
Process rating: all ten parameters 53/100
- 0Result and completion. Does not say what the result is
- 0Inputs and preconditions. Does not say what the process needs to start
- 0Failures and branches. Linear process with no failure handling
- 0Progress reporting. Says nothing while it works
- 20When it triggers. No condition that starts the skill
- 100Tools and files. No external tools needed
- 100Steps. 15 steps
- 100Consistency. Name and required fields are in place
- 100Execution cost. Instruction body is 603 tokens
- 100Running it twice. No mutating operations
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +3Output format is not stated: the model decides each time
- +2Single-language instructions
- +3Description length 342: enough signal without eating the budget
- +4Structure: 10 headings
- +3Step-by-step instructions: 15 items
- +4Has examples (1 code blocks)
- +4Reference files are cited in the instructions (8 of 8)
- +1License stated
Quality base 70; lint remarks subtract, signals add up to 100. Result: 58.