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Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[98,99,100,101,102,103,104,105,78,79,106,107,108,109,110,111,112,113,114,115],"risk","risk management specialist","management","risk management","risk evaluation","product","Evaluation","lifecycle","risk matrix","iso","medical","iso 14971","identification","information","post-production","tree","matrix","implementing",{"skillNo":117,"name":118,"nameZh":6,"description":119,"descriptionZh":6,"repositoryFullName":7,"ownerLogin":8,"ownerAvatarUrl":9,"ownerAccountNo":10,"ownerDisplayName":11,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":120,"categories":121,"keywords":122,"publishedAt":34},"01M6KC3HF5ZFSSP2NZF68PEPFB","regulatory-affairs-head","Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017\u002F745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[123,124,125,126,127,128,129,130,131,79,132,133,134,135,136,137,138,139,140,90],"regulatory affairs head","regulatory","head","documents","devices","health","plan","write","strategy","standards","queries","manage","strategies","de","users","respond","medical devices","manager",{"skillNo":142,"name":143,"nameZh":6,"description":144,"descriptionZh":6,"repositoryFullName":7,"ownerLogin":8,"ownerAvatarUrl":9,"ownerAccountNo":10,"ownerDisplayName":11,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":145,"categories":146,"keywords":149,"publishedAt":34},"01M6KC34Z8M1559EY1CXYBJB1A","quality-manager-qms-iso13485","ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[147,148],{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},{"categoryNo":23,"categoryName":24,"taxonomyType":25,"taxonomyTypeDesc":26},[150,151,140,28,152,153,154,155,32,79,156,157,158,159,160,161,162,163,90,164],"quality manager qms iso13485","quality","workflows","validation","actions","certification","maintenance","document","systems","records","ISO 13485","organizations","corrective action","internal audit","preparation",{"skillNo":166,"name":167,"nameZh":6,"description":168,"descriptionZh":6,"repositoryFullName":7,"ownerLogin":8,"ownerAvatarUrl":9,"ownerAccountNo":10,"ownerDisplayName":11,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":169,"categories":170,"keywords":172,"publishedAt":34},"01M6KC2FXHBHXYX2ZZ17Y3GDB4","quality-manager-qmr","Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[171],{"categoryNo":68,"categoryName":69,"taxonomyType":25,"taxonomyTypeDesc":26},[173,151,140,174,175,176,177,178,71,179,32,180,124,181,182,183,107,160,90,184],"quality manager qmr","review","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture","leadership","person",{"skillNo":186,"name":187,"nameZh":6,"description":188,"descriptionZh":6,"repositoryFullName":7,"ownerLogin":8,"ownerAvatarUrl":9,"ownerAccountNo":10,"ownerDisplayName":11,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":189,"categories":190,"keywords":198,"publishedAt":34},"01M6KC1VRR5JTDBNZANHPS6VR6","quality-documentation-manager","Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[191,194,197],{"categoryNo":192,"categoryName":193,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":195,"categoryName":196,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000023","Skill与智能体开发",{"categoryNo":68,"categoryName":69,"taxonomyType":25,"taxonomyTypeDesc":26},[199,200,151,140,174,201,202,75,32,203,204,205,206,207,108,208,209,210,211,90],"documentation","quality documentation manager","workflow","change","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control","retention"]