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Search Device , found 9 results

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CAPA Officer Guide

alirezarezvani/claude-skills

Guides medical-device CAPA officers through structured investigation, focused root cause analysis, corrective/preventive action planning, and effectiveness verification while tracking CAPA metrics across the QMS.

FDA Device Regulation Consultant

fda-consultant-specialist

alirezarezvani/claude-skills

Provides FDA regulatory consulting for medical device makers, covering pathway choice (510(k)/PMA/De Novo), QSR compliance, HIPAA readiness, and device cybersecurity guidance when preparing submissions or responding to agency inquiries.

EU MDR Compliance Specialist

mdr-745-specialist

alirezarezvani/claude-skills

Guides teams through EU MDR 2017/745 requirements for device classification, technical documentation, clinical evaluation and post-market surveillance, including Annex workflows, EUDAMED/UDI integration, and Notified Body interactions.

Medical QMS Audit Expert

qms-audit-expert

alirezarezvani/claude-skills

Guides ISO 13485 internal audit programs for medical device QMS, covering planning, execution, finding classification, CAPA verification, and external audit prep to keep audit teams compliant and effective.

Quality Documentation Manager

quality-documentation-manager

alirezarezvani/claude-skills

Manages medical device quality system documents, covering numbering, version control, change workflows, approvals, and 21 CFR Part 11 compliance to keep regulated QMS records auditable and current.

Medical Device QMS Guide

quality-manager-qms-iso13485

alirezarezvani/claude-skills

Guides ISO 13485 implementation, document control, internal audits, CAPA, supplier qualification, and certification support for medical device quality organizations; ideal for compliance documentation, audit preparation, and corrective action planning.

Medical Device Regulatory Lead

regulatory-affairs-head

alirezarezvani/claude-skills

Guides HealthTech and MedTech teams through FDA 510(k)/De Novo/PMA and EU MDR CE marking, drafting strategy documents, agency responses, and multi-market plans for device submissions and compliance.

ISO 13485 Doc Assistant

iso-13485-certification

K-Dense-AI/claude-scientific-skills

Guides medical device teams through gap analysis, templated documents, and requirements interpretation to prepare ISO 13485 quality management documentation.

MedTech Compliance Auditor

fda-medtech-compliance-auditor

sickn33/antigravity-awesome-skills

Turns the assistant into an expert auditor for SaMD and medical device software compliance, reviewing DHFs, protocols, and infrastructure against Part 820, IEC 62304, and related standards while offering severity-tagged findings and corrective guidance.

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