Loading...
Loading...
Found 6 Skills
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
Create security policies, guidelines, compliance documentation, and security best practices. Use when documenting security policies, compliance requirements, or security guidelines.
Assess and classify legal risks using a severity-by-likelihood framework with escalation criteria. Use when evaluating contract risk, assessing deal exposure, classifying issues by severity, or determining whether a matter needs senior counsel or outside legal review.
Framework for documenting compliant patient journeys with touchpoints, consent, and escalation paths.
Create institutional-grade financial documents from templates. Handles analysis reports, buy tickets, compliance memos, Excel model specs, presentations, and onboarding reports.
Generates a cross-referenced U.S. nonprofit annual filing package for state charity-bureau registration. Produces Full Compliance Package, Form-Field Mode, or Executive Briefing with source citations, disclosure cross-checks, and filing instructions. Trigger when the user drafts annual report submissions, renewal packets, penalty-of-perjury certifications, or charity bureau filings. Also trigger on Form RRF-1, CHAR500, BCO-10, nonprofit annual report, charity registration renewal, or fundraiser disclosure attachments.