Profile Details

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★★★★★

☆☆☆☆☆

USD 200 /hr

★★★★★

☆☆☆☆☆

Hire Adam F.

Switzerland

USD 200 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• 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

Work Experience

Senior Consultant

Confinis AG

January 2018 - Present

Investigator

United States Food and Drug Administration

September 2010 - December 2017

Education

Bachelors of Science in Biochemistry

Kennesaw State University

January 2005 - December 2008

Certifications

• Certification details not provided.