Plugins

2 plugins

@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 · plugin

@alirezarezvani

Compliance OS — meta-orchestrator for multi-framework compliance programs spanning 9 frameworks (ISO 27001, ISO 13485, ISO 42001, ISO 14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR). Framework selector, cross-framework control mapper, audit simulator, and consolidated evidence-pool generator (stdlib Python), plus 3 cs-* compliance agents and 3 /cs:* readiness commands.

9 skills · plugin

Results for “fd”

6 skills

fda-qsr-audit-prep

Prepares for FDA QSR audits by asking six forcing questions covering complaints, process validation, DHRs, CAPAs, labeling, and Form 483 history.

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l3-3-fintech-vertical

Applies PCI-DSS v4.0, FINTRAC, SOX, and FDX compliance frameworks across outputs, with a primary focus on payment card industry standards.

acquiring-disk-image-with-dd-and-dcfldd

Create forensically sound bit-for-bit disk images using dd and dcfldd while preserving evidence integrity through hash verification.

24.6k · bundle

dqf-personnel-file-vs-dqf

Use this skill when sorting paperwork between a driver's personnel file and the regulated DQ file. Covers FMCSA-required documents vs employer documents, audit-scope vs HR-scope, retention differences.

dqf-audit-self-assessment

Use this skill when conducting a self-audit of your DQF library before an FMCSA compliance review. Covers the systematic approach to verifying all 12 documents are current, complete, and properly maintained.

Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.