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Search Regulatory Compliance , found 8 results

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FDA Device Regulation Consultant

fda-consultant-specialist

alirezarezvani/claude-skills

Provides FDA regulatory consulting for medical device makers, covering pathway choice (510(k)/PMA/De Novo), QSR compliance, HIPAA readiness, and device cybersecurity guidance when preparing submissions or responding to agency inquiries.

Compliance Report Generator

generating-compliance-reports

jeremylongshore/claude-code-plugins-plus-skills

Automates compliance and security audit reporting for standards such as PCI DSS, HIPAA, SOC 2, and ISO 27001 by using the compliance-report-generator plugin to collect details, format documentation, and streamline regulatory proof.

Granola Data Handling

granola-data-handling

jeremylongshore/claude-code-plugins-plus-skills

Guides admins through exporting Granola meeting artifacts, configuring per-type retention policies, automating GDPR/CCPA workflows, and ensuring archival plus consent notices for regulatory compliance.

Medical Device Regulatory Lead

regulatory-affairs-head

alirezarezvani/claude-skills

Guides HealthTech and MedTech teams through FDA 510(k)/De Novo/PMA and EU MDR CE marking, drafting strategy documents, agency responses, and multi-market plans for device submissions and compliance.

Regulatory Compliance Audit

security-compliance-compliance-check

sickn33/antigravity-awesome-skills

Provides hands-on compliance expertise for GDPR, HIPAA, SOC2, PCI-DSS and other industry standards, guiding audits, control implementation, monitoring, and reporting to keep software systems aligned with regulatory expectations.

Global Customs Compliance Guide

customs-trade-compliance

sickn33/antigravity-awesome-skills

Codified procedures for customs and trade compliance, covering HS tariff classification, documentation, Incoterms, duties, and regulatory controls when importing or exporting goods across jurisdictions.

HealthTech Regulatory Toolkit

alirezarezvani/claude-skills

Suite of 12 production-ready HealthTech/MedTech regulatory and quality management skills covering ISO 13485, MDR 2017/745, FDA 510(k)/PMA, ISO 27001, GDPR/DSGVO, risk management, CAPA, documentation, and audits, plus stdlib Python helpers for compliance workflows.

Customs Trade Compliance

customs-trade-compliance

affaan-m/everything-claude-code

Provides codified customs clearance, tariff classification, denied-party screening, and regulatory response procedures for import/export teams navigating multi-jurisdictional trade compliance and duty optimization.

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