.claude/skills/medical-device-postmarketRuntime, accounts, dependencies, permissions, network behavior and task quality remain untested.
医疗器械上市后监管(Post-Market Surveillance, PMS)实操手册——中美欧日四市场上市后义务对照(不良事件报告、PSUR 定期安全报告、FSCA/召回现场安全纠正、PMCF 上市后临床跟踪)、各市场报告时限与流程清单(美国 21 CFR 803 致死 30 天/严重 90 天、欧盟 MDCG 2022-21 PSUR 频率、中国 2018 年 1 号令报告时限、日本 PMDA)、PMS 计划与 PSUR 撰写框架、监测-报告-纠正闭环落地,附零依赖本地工具一键查询义务对照、报告时限与生成 PMS/PSUR 框架。面向医械法规、质量与临床负责人,拿证后的持续合规一站理清。
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These checks parse the fixed package against dated platform rules. They do not execute the Skill or verify task behavior.
.claude/skills/medical-device-postmarketRuntime, accounts, dependencies, permissions, network behavior and task quality remain untested.
.agents/skills/medical-device-postmarketRuntime, accounts, dependencies, permissions, network behavior and task quality remain untested.
skills/medical-device-postmarketRuntime, accounts, dependencies, permissions, network behavior and task quality remain untested.
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clawhub install @zhaoxinghua09-cell/medical-device-postmarketclawhub inspect @zhaoxinghua09-cell/medical-device-postmarket --version 1.1.0This automated, non-executing scan is bound to this release hash. It is not a safety certification and may contain false positives or false negatives.
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sha256:f3b66e2adeb5bb97722bb55b65aa6fdefe03c133021f5e0ae4eacd4247dcaffeATTESTATION.mdLICENSE.mdmanifest.jsonreferences/上市后监管知识库.mdSECURITY_AUDIT.mdskill-card.mdSKILL.mdtools/pms_toolkit.pyverify/gen_security_radar.pyverify/pms_quality_test.pyverify/security_results.jsonverify/security-radar.svgv1.1.0: published edition - medical device post-market surveillance playbook, four-market (US/EU/CN/JP) obligation comparison (adverse event reporting, PSUR, FSCA/recall, PMCF), report timelines (US 21 CFR 803 30/90-day, EU MDCG 2022-21, China 2018 Order No.1, Japan PMDA), PMS plan and PSUR frameworks, monitor-report-correct loop; 5-command toolkit