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Found 900 Skills
Senior GDPR/DSGVO expert and internal/external auditor for data protection compliance. Provides EU GDPR and German DSGVO expertise, privacy impact assessments, data protection auditing, and compliance verification. Use for GDPR compliance assessments, privacy audits, data protection planning, and regulatory compliance verification.
ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
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.
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
Build communication features with Twilio: SMS messaging, voice calls, WhatsApp Business API, and user verification (2FA). Covers the full spectrum from simple notifications to complex IVR systems and multi-channel authentication. Critical focus on compliance, rate limits, and error handling. Use when: twilio, send SMS, text message, voice call, phone verification.
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
Information Security Management System auditing for ISO 27001 compliance, security control assessment, and certification support
Implement comprehensive cloud security across AWS, Azure, and GCP with IAM, encryption, network security, compliance, and threat detection.
Implement WCAG compliance using semantic HTML, ARIA, keyboard navigation, and screen reader support. Use when building inclusive applications for all users.