iec-62304
IEC 62304 medical device software lifecycle framework. Risk classification, software safety classification (A/B/C), design control, verification, validation, and regulatory documentation for FDA/EU MDR submissions.
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IEC 62304 medical device software lifecycle framework. Risk classification, software safety classification (A/B/C), design control, verification, validation, and regulatory documentation for FDA/EU MDR submissions.
Generates structured personal injury demand summaries covering liability analysis, chronological injury documentation, itemized damages, and settlement positioning. Covers MVA, premises liability, product defect, and medical malpractice claims. Use when preparing settlement packages, demand lette...
Drafts regulatory-compliant informed consent forms for healthcare procedures, clinical trials, research participation, or professional services. Incorporates HIPAA, FDA, IRB/Common Rule, and ICH-GCP requirements as applicable. Use when drafting surgical consent, research participant agreements, c...
Creates verified, Bates-cited chronological summaries of medical records for litigation. Extracts treatment timelines, providers, diagnoses, procedures, medications, and causation evidence with every clinical fact traceable to a specific Bates range. Identifies gaps, inconsistencies, pre-existing...
Drafts Investigator Agreements for FDA-regulated clinical trials between sponsors and principal investigators. Covers 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), IRB governance, data integrity, IP, indemnification, financial terms, and termination. Use when preparing clinical trial investigator...
Produces structured medical malpractice case summaries from medical records for personal injury litigation. Extracts chronological care narratives, identifies potential standard-of-care breaches, traces causation, assesses damages, and flags expert needs and statute of limitations issues. Use whe...
Drafts a Medical Director Agreement between a healthcare organization and a physician, structured for Anti-Kickback Statute and Stark Law safe harbor compliance. Covers appointment, duties, FMV compensation, independent contractor status, restrictive covenants, HIPAA obligations, and regulatory s...
Reviews coded encounters for accuracy using OIG compliance guidelines and CMS documentation requirements. Use when auditing medical codes, reviewing coding accuracy, or conducting compliance audits.
Extracts and reconciles medical provider, wage-loss, and insurance/lien data from personal injury plaintiff fact sheets and initial disclosures against builder draft responses. Use when the user mentions PFS analysis, medical provider reconciliation, wage loss audit, insurance lien tracking, PI d...
Generates structured pharmaceutical regulatory compliance summaries covering FDA approval pathways, patent/IP intersections (Orange Book, Hatch-Waxman), and marketing restrictions (off-label, DTC, Anti-Kickback). Use when preparing FDA compliance overviews, submission readiness assessments, or pr...
Generates a comprehensive, HIPAA-compliant Incident Response Plan for medical companies, including team structures, tiered classification systems, threat feeds, handler checklists, SIEM policies, red teaming details, RACI matrices, and governance processes.
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
Guide a reporter through filing a private vulnerability report and route it to the project's configured private channel — never to a public issue tracker
Implement Intercom data handling for GDPR, contact export, data retention, and PII. Use when handling sensitive data, implementing data export/deletion requests, or ensuring compliance with privacy regulations for Intercom integrations. Trigger with phrases like "intercom data", "intercom PII", "...
Spearphishing simulation is a targeted social engineering attack vector used by red teams to gain initial access. Unlike broad phishing campaigns, spearphishing uses OSINT-derived intelligence to craf
Detect and flag personally identifiable information (PII) in text, code, and configurations
Offensive security tools and techniques integration
Einstieg, Schnelltriage und Fallrouting im Betreuungsrecht-Plugin für ehrenamtliche Familienbetreuer, Berufsbetreuer, Angehörige, Betroffene und anwaltliche Begleiter. Fragt Rolle, Aufgabenkreise, Fristen, Unterlagen, Risiken, Wunsch der betreuten Person und Ziel-Output ab, schlägt passende Fachm
Krankenversicherungs-Bescheide verständlich erklärt: Aufbau, Ablehnungsgründe, Rechtsbehelfsbelehrung und konkrete nächste Schritte für Betroffene ohne Rechtskenntnisse im Krankenkassen-/Krankenversicherungsrecht: prüft konkret die einschlägigen Tatbestandsmerkmale, Fristen, Belege und Rechtsprec...
Berliner Start-up-HR: AGG-Beschwerdestelle: Beschwerde aufnehmen, prüfen, Maßnahmen wählen, Fristen und Vertraulichkeit sichern. Geführter HR-mit Datenschutzfilter, Arbeitsrechtsrouting, Payroll-/DATEV-Schnittstelle, Chef-Briefing und nächstem konkretem Schritt im Startup-HR Berlin.
Baut aus den Belegen eines Fahrgastrechte-Mandats ein beA-konformes Anlagenkonvolut. Verwendet zum bestehenden Schriftsatz (Forderungsschreiben Widerspruch Schlichtungsantrag Klage) die Belege Buchungsbestaetigung E-Ticket Verspaetungsbestaetigung Foto Anzeigetafel App-Screenshots Belege zu Ausla...
Familienkonflikte in der Betreuung: trennt Betreuerrolle, Angehörigenrolle und Eigeninteressen, prüft Kontaktkonflikte, Geldmisstrauen, Geschwisterstreit, Heimdruck, Datenschutz und gerichtliche Eskalation mit klarer Rollen- und Belegmatrix.
Wunschermittlung und unterstützte Entscheidung nach § 1821 BGB: hilft Betreuern, Wünsche, frühere Präferenzen, mutmaßlichen Willen, Kommunikationshilfen und Schutzgrenzen sauber zu dokumentieren, ohne die betreute Person zu entmündigen.
Einstieg, Schnelltriage und Fallrouting im Urteilsbauer Relationsmacher-Plugin. Fragt Rolle, Ziel, Fristen, Unterlagen, Risiken und Wunsch-Output ab, schlägt passende Fachmodule aus diesem Plugin vor und führt in einen klaren Arbeitsplan. Bei Dokument-Upload ohne Begleittext reagiert der Skill ei
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