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A comprehensive skill for implementing and managing Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and global regulatory standards. This tool guides users through critical security processes, including risk assessments, control implementation, gap analyses, and preparing for audits. Essential for HealthTech and MedTech companies ensuring data privacy and compliance.

This guide defines the role and responsibilities of a Senior Quality Manager Responsible Person (QMR) for highly regulated MedTech and HealthTech environments. It covers essential functions under ISO 13485, including leading management reviews, establishing quality objectives, monitoring performance KPIs, and maintaining strict regulatory compliance oversight. Use this resource when developing a Quality Management System (QMS) or managing regulatory accountability.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

This specialized AI acts as an auditor for Medical Devices (SaMD) compliance. It reviews critical documentation like Design History Files (DHF) and technical files against major global regulations, including 21 CFR Part 820, IEC 62304, and ISO 13485. It identifies compliance gaps, cites specific regulations, and provides actionable remediation steps to prepare for regulatory audits.

This router bundles 15 specialized compliance skills crucial for HealthTech and MedTech organizations. It provides structured guidance across major global regulations, including ISO 13485 QMS, EU MDR, FDA submissions, GDPR, and the EU AI Act. Use this when a compliance request is complex and needs to be accurately directed to a specific technical skill area (e.g., risk management, CAPA, data security).

Audits medical device software compliance with IEC 62304, 21 CFR Part 820/11, ISO 13485, and ISO 14971; reviews DHFs, validation protocols, CAPA, and technical files to identify regulatory gaps.

Validates 1EdTech/IMS Global OneRoster v1.1 and v1.2 CSV roster sets for manifest integrity, bulk vs delta strictness, foreign key references, and encoding sanitization. Use for pre-flight checks before SIS/Clever/ClassLink ingestion.

This skill provides strategic advisory for education technology founders and product leaders. It covers compliance frameworks like FERPA and COPPA, market dynamics between K-12, higher education, and corporate learning, and district sales strategies. Use it to scope edtech products, navigate procurement processes, or analyze student data privacy requirements. It supports compliance checking and market selection guidance.