ReddRadar
Topic: coding-agent-plugins
507 skills in this topic.
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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 2017/745; 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.
alirezarezvani/claude-skills 8,805
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risk-management-specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. 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.
alirezarezvani/claude-skills 8,805
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soc2-compliance
Use when the user asks to prepare for SOC 2 audits, map Trust Service Criteria, build control matrices, collect audit evidence, perform gap analysis, or assess SOC 2 Type I vs Type II readiness.
alirezarezvani/claude-skills 8,805