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Mdr 745 Specialist
作者
Alireza Rezvani
· GitHub ↗
· v2.1.1
· MIT-0
1747
总下载
1
收藏
8
当前安装
2
版本数
在 OpenClaw 中安装
/install mdr-745-specialist
功能描述
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Ann...
安全使用建议
This skill appears internally consistent and implements what it claims: MDR guidance, templates, and a local gap-analysis script. Before installing or running it: (1) verify the author's identity/source if you require provenance (there's no homepage listed), (2) review the Python script yourself or run it in a sandboxed environment if you have concerns, (3) do not supply unrelated secrets or system credentials to the skill, and (4) if you will rely on the output for regulatory submissions, have a qualified clinical/regulatory evaluator review the results for completeness and correctness.
功能分析
Type: OpenClaw Skill
Name: mdr-745-specialist
Version: 2.1.1
The skill bundle is a specialized tool for EU MDR 2017/745 medical device compliance. The Python script (mdr_gap_analyzer.py) is a standard CLI utility for performing gap assessments based on user input, containing no network activity, file system modifications, or obfuscated code. The documentation files (SKILL.md and references/) provide legitimate regulatory guidance and templates without any evidence of prompt injection or malicious instructions.
能力评估
Purpose & Capability
Name and description (EU MDR specialist) match the manifest: SKILL.md contains classification, technical documentation, clinical evidence and PMS guidance, and the included scripts/references implement a gap-analysis and templates appropriate to that purpose. The presence of a local Python 'mdr_gap_analyzer.py' is coherent with a compliance-assessment tool. The only minor provenance issue is that the skill's source/homepage is unknown (no publisher link), but that does not make the requested capabilities disproportionate.
Instruction Scope
SKILL.md instructions are scoped to MDR classification, documentation and evidence workflows. The instructions do not direct the agent to read unrelated system files, request environment variables, or post data to external endpoints. They don't give open-ended permissions ('gather whatever context you need').
Install Mechanism
No install spec (instruction-only) — lowest install risk. A single Python script is included but there is no download-from-URL, package installation, or extract step. Running the script locally would require Python, which is typical and reasonable for this tool.
Credentials
The skill declares no required environment variables, credentials, or config paths. The included code and docs do not reference secrets or external service keys. Requested access is proportional to the stated functionality.
Persistence & Privilege
Flags show default privileges (always: false, agent invocation enabled). The skill does not request permanent/force-included presence and does not appear to modify other skills or system-wide agent settings.
如何使用
- 确保已安装 OpenClaw（本地或 Docker 部署）
- 在对话框中输入安装命令：
/install mdr-745-specialist - 安装完成后，直接呼叫该 Skill 的名称或使用
/mdr-745-specialist触发 - 根据 Skill 的参数说明提供必要输入，即可获得结构化输出
版本历史
v2.1.1
v2.1.1: optimization, reference splits
v1.0.0
- Initial release of mdr-745-specialist: an EU MDR 2017/745 compliance skill for medical device manufacturers.
- Supports device classification (Annex VIII), technical documentation (Annex II/III), clinical evidence (Annex XIV), and post-market surveillance.
- Covers software rules, EUDAMED integration, UDI labeling, notified body engagement, and PMS/PMCF processes.
- Provides structured workflows, checklists, and example classifications to guide MDR compliance.
- Includes reference documentation for Annex VIII classification and conformity assessment routes.
元数据
常见问题
Mdr 745 Specialist 是什么？
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Ann... 它是一个面向 Claude Code / OpenClaw 的 AI Agent Skill 插件，目前累计下载 1747 次。
如何安装 Mdr 745 Specialist？
在 OpenClaw 或 Claude Code 对话框中运行命令「/install mdr-745-specialist」即可一键安装，无需额外配置。
Mdr 745 Specialist 是免费的吗？
是的，Mdr 745 Specialist 完全免费，采用 MIT-0 许可证，可自由下载、安装和使用。
Mdr 745 Specialist 支持哪些平台？
Mdr 745 Specialist 跨平台运行，可在任意部署了 OpenClaw / Claude Code 的环境中使用（cross-platform）。
谁开发了 Mdr 745 Specialist？
由 Alireza Rezvani（@alirezarezvani）开发并维护，当前版本 v2.1.1。
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