プロフィール詳細

プロジェクトを作成

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Devin M.に依頼

United States

Quality Systems Consultant | ISO 13485 • FDA 21 CFR 820 • Medical Devices

プロフィール概要

I help medtech companies design, assess, and improve quality systems to ensure regulatory compliance, streamline development, and prepare for audits. With over a decade of hands-on experience, I specialize in ISO xxxxxxxxxx implementation, FDA QSR compliance, internal audits, and remediation planning. Whether you're launching a novel Class II device, responding to Notified Body findings, or simply need a lean QMS that works, I offer clear, actionable support tailored to startups, small manufacturers, and advisory teams.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance

サービス

• Writing
• Consulting
• Product Development

Writing Technical Writing

Consulting Operations Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Product Evaluation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Primary Consultant

Quality System Modelers, LLC

5月 2023 - 現在

学歴

MBA

University of Phoenix

6月 2003 - 8月 2005

BS in Business / Information Systems

University of Phoenix

5月 1998 - 6月 2001

認定資格

• Certified Manager of Quality/Organizational Excellence (expires 31-Dec-2027)

  American Society for Quality

  https://dmcelroy.com/

  11月 2023 - 現在

• ISO 9001 Lead Auditor

  bsi

  https://dmcelroy.com/

  10月 2023 - 現在

• ISO 13485 lead auditor

  bsi

  https://dmcelroy.com/

  9月 2023 - 現在

• Six Sigma Green Belt

  The Juran Institute

  https://dmcelroy.com/

  5月 2005 - 現在