Firm Medtech Pack

该 Skill 是面向医疗器械、数字健康与医药研发团队的行业配置包，按 RA、研发、质量、法务、运营等部门激活 Agent，覆盖 FDA 510(k)、CE/MDR、ISO 13485、IEC 62304、HIPAA、21 CFR Part 11 等合规主题，并提供监管申报准备与不良事件分流的提示词模板。

romainsantoli-web

热度 71.25

最近更新 2026-05-17 13:01:20

分类：安全依赖：MCP 服务应用场景：法律文档 / 报告撰写 / 工作流 / 研究

安装技能

复制下面的话术发给你的 Agent，它会通过 secure-skills 检索并安装该技能。

执行命令安装此 skill： npx secure-skills-cli add firm-medtech-pack

Metadata

name: firm-medtech-pack
version: 1.0.0
description: Curated skill bundle for medical device companies, digital health startups and pharma R&D teams. Activates the firm pyramid with RA (Regulatory Affairs), Clinical, R&D and Quality agents pre-configured for FDA/CE compliance, clinical documentation and pharmacovigilance workflows.
author: romainsantoli-web
license: MIT
metadata: {"openclaw":{"requires":{"env":[],"bins":[]},"tools":["sessions_send","sessions_spawn","sessions_history"],"primaryEnv":""}}
tags: ["medtech","healthtech","pharma","regulatory","fda","ce-marking","firm-pack","sector"]

firm-medtech-pack

Sector bundle for medical technology & digital health environments.

Activated departments

Department	Services activated	Focus
RA	Regulatory Affairs · Compliance Legal	FDA 510(k), CE Marking, MDR
Research Development	Research Discovery · R&D Prototyping	Clinical evidence, biomarker research
Quality	Compliance Auditing · Reliability · Security	ISO 13485, IEC 62304
Legal	Privacy/Data Protection · IP	HIPAA, patient data, patents
Operations	Documentation · SRE/Incident	DHF, adverse event reporting

Recommended ClawHub skills to install alongside

npx clawhub@latest install academic-research        # PubMed / clinical trial search
npx clawhub@latest install admet-prediction         # Drug candidate ADMET analysis
npx clawhub@latest install pdf-documents            # Clinical study PDF parsing
npx clawhub@latest install arc-security-audit       # 21 CFR Part 11 audit trail
npx clawhub@latest install firm-orchestration       # A2A orchestration backbone

Firm configuration overlay

{
  "agent": {
    "model": "anthropic/claude-opus-4-6",
    "workspace": "~/.openclaw/workspace/medtech-firm"
  },
  "agents": {
    "defaults": {
      "sandbox": { "mode": "non-main" }
    }
  }
}

Prompt: regulatory submission prep

Use firm-orchestration with:
  objective: "Prepare 510(k) substantial equivalence summary for continuous glucose monitor"
  departments: ["ra", "research_development", "quality"]
  constraints: ["FDA guidance K020431 reference", "predicate device: Dexcom G6"]
  definition_of_done: "510(k) summary draft with predicate comparison table"
  delivery_format: "structured_document"

Prompt: adverse event review

Use firm-orchestration with:
  objective: "Classify and triage Q4 adverse event reports against MDR Art. 87"
  departments: ["ra", "quality", "legal"]
  constraints: ["read-only access", "anonymize patient identifiers in output"]
  definition_of_done: "Triage matrix with reportability decisions per event"
  delivery_format: "markdown_report"

Regulatory coverage

Standard	Department	Service
FDA 510(k) / PMA	RA	Regulatory Affairs
EU MDR 2017/745	RA + Legal	Regulatory + Privacy
ISO 13485:2016	Quality	Compliance Auditing
IEC 62304	Engineering	AI Engineering
HIPAA	Legal	Privacy/Data Protection
21 CFR Part 11	Quality	Security
ISO 14971	RA + Quality	Risk Management

Security notes

PHI (Protected Health Information): SECURE_PRODUCTION_MODE=true mandatory
All outputs must be anonymized: enforce via POLICY_BLOCKED_TOOLS for export
Audit trail required by 21 CFR Part 11: AUDIT_ENABLED=true

💎 Support

Si ce skill vous est utile, vous pouvez soutenir le développement :

Dogecoin : DQBggqFNWsRNTPb6kkiwppnMo1Hm8edfWq