Packs

1 pack

@alirezarezvani

14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.

10 skills · pack

Results for “regulatory-compliance”

8 skills

implementing-azure-defender-for-cloud

Enables comprehensive security monitoring across Azure subscriptions, including cloud security posture management, workload protection, regulatory compliance assessment, and adaptive security controls.

24.6k · bundle

Generate Non-functional Requirements (NFR): performance, security, availability, scalability, compliance, localization. Use on /nfr command, or when the user asks for "non-functional requirements", "NFR", "performance requirements", "security requirements", "SLA", "compliance requirements", "load requirements", "uptime requirements", "regulatory requirements", "GDPR". Sixth step of the BA Toolkit pipeline.

More results

Measures whether coding agents actually follow skills, rules, or agent definitions by generating test scenarios, running agents, and classifying tool calls to report compliance rates.

Automatically measures whether coding agents follow skills, rules, or agent definitions by generating scenarios at multiple prompt strictness levels, running agents, classifying tool calls, and reporting compliance rates with full timelines.

011-main-b36446cb

Enforces GDPR-compliant deployment practices for Google Cloud Run, including Frankfurt region verification, PII-safe logging, data anonymization, retention policies, and CSP configuration.

Apply GDPR-compliant engineering practices across your codebase, covering API design, data models, authentication, logging, retention, and cloud infrastructure.

36.2k · bundle

compliance-auditor

Federal acquisition compliance auditor for the active Theseus workspace, backed by live FAR/DFARS text via the vendored `ecfr` MCP. USE WHEN the user asks to audit FAR/DFARS clause coverage, validate that cited clauses actually exist in eCFR (catch fabricated or typo'd numbers), check whether a cited clause has been amended since the solicitation issued, validate regulatory references (NIST SP, DAFI, MIL-STD), check that every "shall" requirement has a deliverable, find missing compliance artifacts, audit proposal_instruction ↔ evaluation_factor coverage (UCF Section L↔M or non-UCF equivalent — FAR 16 task orders, FOPRs, BPA calls, OTAs), or "are we compliant with the proposal instructions?". Cross-references the workspace's clause / regulatory_reference / requirement / deliverable / compliance_artifact entities against live eCFR and flags gaps with severity. Format-agnostic. DO NOT USE FOR drafting compliant prose (use proposal-generator) or extracting clauses (Theseus pipeline does that automatically).

clinical-reports

Generate comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports, clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP, H&P, discharge summaries) with templates, regulatory compliance, and validation tools.

30.2k · bundle