プロフィール詳細

プロジェクトを作成

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Adam F.に依頼

Switzerland

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance

プロフィール概要

I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate as a coach assisting with market clearance, internal audits, mock inspections, design, manufacturing, validation, and compliance.

専門分野

• ★ Medical Devices
• ☆ Cybersecurity
• ☆ Engineering Design
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ Medical Affairs
• ☆ Software Development
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ PreMarket Approval (PMA) Applications

サービス

• Writing
• Research
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis, Data Visualization

Product Development Formulation, Stability/Shelf Life Testing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Senior Consultant

Confinis AG

1月 2018 - 現在

Investigator

United States Food and Drug Administration

9月 2010 - 12月 2017

学歴

Bachelors of Science in Biochemistry

Kennesaw State University

1月 2005 - 12月 2008

認定資格

• 認定資格の詳細は未入力です。