Loading...
Loading...
Found 1,565 Skills
Product marketing skill for positioning, GTM strategy, competitive intelligence, and product launches. Covers April Dunford positioning, ICP definition, competitive battlecards, launch playbooks, and international market entry.
Microsoft 365 tenant administration for Global Administrators. Automate M365 tenant setup, Office 365 admin tasks, Azure AD user management, Exchange Online configuration, Teams administration, and security policies. Generate PowerShell scripts for bulk operations, Conditional Access policies, license management, and compliance reporting. Use for M365 tenant manager, Office 365 admin, Azure AD users, Global Administrator, tenant configuration, or Microsoft 365 automation.
Creates formal academic research papers following IEEE/ACM formatting standards with proper structure, citations, and scholarly writing style. Use when the user asks to write a research paper, academic paper, or conference paper on any topic.
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.
App Store Optimization toolkit for researching keywords, optimizing metadata, and tracking mobile app performance on Apple App Store and Google Play Store.
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.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
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.
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
Information Security Management System auditing for ISO 27001 compliance, security control assessment, and certification support