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Quality Management Oversight

quality-manager-qmr

alirezarezvani/claude-skills

Defines the Senior Quality Manager Responsible Person (QMR) role for HealthTech/MedTech firms, covering ISO 13485 Clause 5.5.2 responsibilities, management review workflows, and KPI-driven compliance governance to ensure QMS effectiveness and regulatory accountability.

Medical Device Regulatory Lead

regulatory-affairs-head

alirezarezvani/claude-skills

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.

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