BD ai-medical-device-compliance
AI/ML 医疗器械全球注册合规实操手册——覆盖美国FDA（510(k)/De Novo/PMA、PCCP预设变更控制、QMSR、网络安全SBOM）、欧盟（MDR Rule 11分类、AI Act高风险2028-08-02、CER/PMCF临床评价）、中国NMPA（分类界定、2026更新指南、变更注册、1000例数据本地化、创新通道）三地完整注册路径，含临床证据要求对比、变更管理与全生命周期（GMLP/算法漂移）、三地费用周期对比与并行出海策略。面向医械法规工程师、研发与国际业务负责人，附零依赖本地工具一键查询三地分类、路径、费用周期估算与变更触发判定。
AI/ML 医疗器械全球注册合规实操手册——覆盖美国FDA（510(k)/De Novo/PMA、PCCP预设变更控制、QMSR、网络安全SBOM）、欧盟（MDR Rule 11分类、AI…
As a process D 46/100 · Unfinished process — 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 · 0
✓ No critical or high findings
Files scanned: 18. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
description-long-hermesdescription is 280 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 46/100
- 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
- 60Tools and files. Uses tools (python) that frontmatter does not declare
- 100Steps. 18 steps
- 100Consistency. Name and required fields are in place
- 100Execution cost. Instruction body is 774 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 280: enough signal without eating the budget
- +4Structure: 10 headings
- +3Step-by-step instructions: 18 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: 68.