quality-documentation-manager
Senior Quality Documentation Manager for comprehensive documentation control and regulatory document review. Provides document management system design, change control, configuration management, and regulatory documentation oversight. Use for document control system implementation, regulatory document review, change management, and documentation compliance verification.
regulatory-affairs-head
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic quality leadership. Use for quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning.
fda-consultant-specialist
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
clinical-decision-support
Generate professional clinical decision support (CDS) documents for pharmaceutical and clinical research settings, including patient cohort analyses (biomarker-stratified with outcomes) and treatment recommendation reports (evidence-based guidelines with decision algorithms). Supports GRADE evidence grading, statistical analysis (hazard ratios, survival curves, waterfall plots), biomarker integration, and regulatory compliance. Outputs publication-ready LaTeX/PDF format optimized for drug development, clinical research, and evidence synthesis.
clinical-reports
Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology/pathology/lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP, H&P, discharge summaries). Full support with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools.
report-standards-analysis
Specialized skill for analyzing institutional and commercial space standards to identify gaps and opportunities for LORS.
nist-compliance
NIST 800-53r5 control implementation, tagging, evidence collection, and compliance automation for security frameworks
cto-risk-resilience
Expert methodology for identifying, assessing, and mitigating technical and operational risks including security, incidents, compliance, and disaster recovery.
politique-confidentialite
Guide complet pour la rédaction de politiques de confidentialité conformes au RGPD. Contient les recommandations CNIL 2020, un template de référence et les bonnes pratiques. À utiliser lors de la rédaction ou révision d'une politique de confidentialité pour un site web ou une application.
politique-cookies
Guide complet pour la rédaction de politiques cookies conformes au RGPD et à la directive ePrivacy. Contient les recommandations CNIL 2020, un template de référence et les bonnes pratiques. À utiliser lors de la rédaction ou révision d'une politique cookies pour un site web ou une application.
whistleblower-policy-fr
Guide pour (a) évaluer la conformité d'un dispositif lanceur d'alerte existant ou (b) rédiger une politique de signalement conforme sur la base d'un template fourni. Couvre la Directive UE 2019/1937, la loi Sapin II modifiée (Waserman 2022), le décret 2022-1284, le référentiel CNIL, les spécificités fonction publique et le devoir de vigilance.
secrets-rotation
Implement automated secrets rotation for API keys, credentials, certificates, and encryption keys. Use when managing secrets lifecycle, compliance requirements, or security hardening.
treatment-plans
Generate concise (3-4 page), focused medical treatment plans in LaTeX/PDF format for all clinical specialties. Supports general medical treatment, rehabilitation therapy, mental health care, chronic disease management, perioperative care, and pain management. Includes SMART goal frameworks, evidence-based interventions with minimal text citations, regulatory compliance (HIPAA), and professional formatting. Prioritizes brevity and clinical actionability.
iso-13485-certification
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.
clinical-decision-support
Generate professional clinical decision support (CDS) documents for pharmaceutical and clinical research settings, including patient cohort analyses (biomarker-stratified with outcomes) and treatment recommendation reports (evidence-based guidelines with decision algorithms). Supports GRADE evidence grading, statistical analysis (hazard ratios, survival curves, waterfall plots), biomarker integration, and regulatory compliance. Outputs publication-ready LaTeX/PDF format optimized for drug development, clinical research, and evidence synthesis.
clinical-reports
Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology/pathology/lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP, H&P, discharge summaries). Full support with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools.
fda-database
Query openFDA API for drugs, devices, adverse events, recalls, regulatory submissions (510k, PMA), substance identification (UNII), for FDA regulatory data analysis and safety research.