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Hire Loai K.

United States

FDA 510(k) Consultant | Medical Device Regulatory Affairs Expert at Cruxi.ai

Profile Summary

Experienced Regulatory Affairs Consultant specializing in US FDA 510(k) submissions for medical devices. I provide end-to-end strategic consulting to help manufacturers navigate the complex regulatory landscape and achieve market clearance. My core expertise includes: FDA 510(k) Premarket Notification: Strategic planning, predicate device selection, and full submission preparation. Regulatory Strategy: Gap analysis, classification determination, and pathway assessment. Technical Documentation: Writing and reviewing clinical evaluation reports (CERs) and eSTAR submissions. I am currently the Lead Regulatory Consultant at Cruxi, where we streamline the FDA submission process. Specialized Focus: FDA 510(k) Consulting Services: https://cruxi.ai/pages/regulatory/fda-510k-consultant.html

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing

Work Experience

Cruxi

- Present

Education

MA in Regulatory Affairs

University of Roma "La Sapienza" - Italy

January 2019 - January 2025

Certifications

• RA

  RAC

  January 2023 - Present