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Search Medical Device , found 20 results

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Systematic CAPA Management For QMS

alirezarezvani/claude-skills

A comprehensive guide for Corrective and Preventive Action (CAPA) management within Quality Management Systems (QMS), specifically tailored for medical devices. It covers the entire investigation lifecycle, including root cause analysis (RCA) using methodologies like 5-Why and Fishbone diagrams, developing robust corrective actions, and verifying effectiveness to ensure continuous compliance and quality improvement.

FDA Medical Device Regulatory Compliance Guide

fda-consultant-specialist

alirezarezvani/claude-skills

Comprehensive guidance for medical device manufacturers navigating complex FDA regulatory requirements. Covers device classification, submission pathways (510(k), PMA, De Novo), Quality Management System Regulation (QMSR/ISO 13485), HIPAA compliance, and cybersecurity best practices. Use this when determining the correct regulatory route for a new or modified device.

EU MDR Medical Device Compliance Specialist

mdr-745-specialist

alirezarezvani/claude-skills

A comprehensive guide for achieving compliance with the EU MDR 2017/745. It covers crucial aspects including medical device classification (Annex VIII), developing technical documentation (Annex II/III), planning clinical evaluation (CER), and establishing post-market surveillance (PMS/PSUR) systems. Ideal for regulatory specialists preparing for Notified Body audits or needing to gap-check technical files.

QMS Audit Expert for Medical Devices

qms-audit-expert

alirezarezvani/claude-skills

This comprehensive guide provides expertise in conducting ISO 13485 internal audits for medical device Quality Management Systems (QMS). It covers the full audit lifecycle, including risk-based planning, systematic evidence collection, classifying nonconformities (Major/Minor), and managing CAPA verification to ensure regulatory compliance and continuous improvement.

Quality Documentation Control Management

quality-documentation-manager

alirezarezvani/claude-skills

A comprehensive guide for designing and managing document control systems for ISO 13485-compliant Quality Management Systems (QMS), specifically tailored for the medical device industry. This resource covers document numbering, version control, change management workflows, approval processes, and ensures compliance with rigorous standards like 21 CFR Part 11, including electronic signatures and audit trails.

ISO 13485 Quality Manager

quality-manager-qms-iso13485

alirezarezvani/claude-skills

Implements and maintains ISO 13485 QMS for medical device organizations, covering gap analysis, documentation control, internal audits, supplier qualification, and CAPA tracking to keep regulatory programs audit-ready.

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.

Medical Device Risk Management Specialist

risk-management-specialist

alirezarezvani/claude-skills

A comprehensive guide for implementing ISO 14971:2019 risk management across the entire medical device lifecycle. Covers planning, hazard identification, risk analysis (FMEA, FTA), risk evaluation, risk control, and post-market surveillance. Essential for achieving regulatory compliance in medical device development.

ISO 13485 Documentation Assistant

iso-13485-certification

K-Dense-AI/claude-scientific-skills

Guides medical device teams through preparing ISO 13485:2016 Quality Management System documentation by combining gap analysis, requirements references, templates, and step-by-step creation workflows for manuals, procedures, and compliance artifacts.

Medical Device Compliance Auditor

fda-medtech-compliance-auditor

sickn33/antigravity-awesome-skills

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.

ISO 13485 Certification Documentation Assistant

iso-13485-certification

K-Dense-AI/scientific-agent-skills

A comprehensive toolkit for medical device manufacturers seeking ISO 13485 certification. This skill guides users through gap analysis, creating mandatory Quality Management System (QMS) documentation, and ensuring compliance with global medical device regulations (e.g., EU MDR, FDA QMSR). It provides templates, guidance, and structured processes for foundational QMS documents like Quality Manuals and CAPA procedures.

FDA QSR Audit Preparation Checklist

fda-qsr-audit-prep

alirezarezvani/claude-skills

A comprehensive simulation tool designed to pressure-test medical device manufacturers' Quality System Regulation (QSR) compliance against FDA standards (21 CFR 820). It covers six critical areas: complaint handling, process validation, device history records (DHRs), CAPAs, labeling, and handling of Form 483 observations. Essential for pre-inspection readiness, internal audits, and regulatory submission planning.

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