プロフィール詳細

プロジェクトを作成

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Jarrell M.に依頼

United States

Medical Device Consultant | Risk & Regulatory Compliance | ISO 14971, IEC 60601, ISO 13485, FDA 510(k), EU MDR

プロフィール概要

I am a medical device consultant with 25 years of experience helping companies bring products to market. I combine strong expertise in regulatory requirements and standards with a solutions-focused approach to ensure documentation is clear, compliant, and ready for regulatory review. Building on that background, I lead Medestan Consulting, where we partner with medical device companies to provide expertise in compliance-focused areas such as regulatory filings, certification testing, human factors evaluation, and remediation support. Our role is to make complex requirements clear and workable — ensuring alignment from early development through submission and post-market activities. By leveraging our experience and teamwork, we help companies move forward with confidence that their products are compliant and aligned with regulatory expectations. Key Expertise: -Medical Device Risk Management (ISO 14971) -FDA 510(k) and EU MDR Documentation -IEC 60601 Series Safety & EMC Certifications -Standards Compliance & Regulatory Documentation -Risk-Based Development and Process Improvement -Gap Analysis, Remediation Planning, and Product Updates -Human Factors Evaluation & Usability Documentation Feel free to reach out to discuss your project needs — I’m happy to explore how I can support your team. Hourly Fee: The hourly fee (listed below) is flexible and can be adapted to the scope and demands of each project to ensure the right balance of value and efficiency.

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ ISO 14971
• ★ Premarket Notification/510(k) Submission
• ☆ Safety & Reliability Engineering
• ☆ Systems Engineering
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Gap Analysis
• ☆ Process Design
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Nonclinical Study Documentation

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing, Technical Writing

Research Gap Analysis

Consulting Scientific and Technical Consulting, Regulatory Consulting

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

職務経験

Sr. Director of R&D / Head of Systems Engineering

Bayer (United States)

6月 2023 - 現在

Founder & Principal Consultant

Medestan Consulting LLC

8月 2018 - 現在

学歴

Bachelor of Science in Electrical Engineering (Electrical Engineering )

University of Pittsburgh

- 現在

認定資格

• 認定資格の詳細は未入力です。

出版物

PATENT

Jarrell Thomas Dante McWilliams (2021). Fluid injection system having various system for controlling and injection procedure.

Jarrell Thomas Dante McWilliams (2018). Fluid injection system having various system for controlling and injection procedure.