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Found 9 Skills
Strategic advisory for digital health and healthtech founders covering HIPAA scope, FDA SaMD vs non-SaMD classification, EHR integration patterns, payor/provider/employer GTM, and value-based care models. Complements the RA/QM compliance domain with software-side strategic guidance. Use when scoping a healthtech idea, classifying PHI, picking a GTM, or when the user mentions HIPAA, PHI, FDA SaMD, EHR integration, telehealth, or digital therapeutics.
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.
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.
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.
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.
Senior Information Security Manager specializing in ISO 27001 and ISO 27002 implementation for HealthTech and MedTech companies. Provides ISMS implementation, cybersecurity risk assessment, security controls management, and compliance oversight. Use for ISMS design, security risk assessments, control implementation, and ISO 27001 certification activities.
Audits HealthTech applications for HIPAA technical safeguards like encryption and audit logging. Use when reviewing healthcare infrastructure or ensuring PHI is handled according to legal security standards.
12 production-ready regulatory affairs and quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO compliance, risk management (ISO 14971), CAPA, document control, and internal auditing. Python tools included (all stdlib-only). Works with Claude Code, Codex CLI, and OpenClaw.
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Provides regulatory strategy development, submission management, pathway analysis, global compliance coordination, and cross-functional team leadership.