Profile Details

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USD 20 /hr

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Hire Prafullakumar P.

India

USD 20 /hr

Medical Device Regulatory Compliance Expert (ISO 13485, Risk management, EU MDR, MDSAP. US FDA).

Profile Summary

I am medical devices regulatory affairs professional having expertise in following points - Author, Reviewer of Global Regulatory Technical Documentation - Author, Reviewer of Quality Management System (QMS) Documentation. - Implementation of QMS at Clients Facility. - Audit Support to Client during External Audit. - Design File preparation for medical device according to EU MDR, FDA & Global compliance - Market Research for Medical device

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
• ☆ 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
• ☆ Nonclinical Study Documentation

Services

• Writing
• Consulting

Writing Technical Writing

Consulting Regulatory Consulting

Work Experience

Regulatory Expert

VREG SOLUTIONS

February 2025 - Present

RA/QA MANAGER

Maven profcon

July 2021 - February 2025

Education

Masters of Science-Medical Device

National Institute of Pharmaceutical Education and Research

June 2019 - April 2021

Certifications

• Certified Internal Auditor

  TNV

  January 2023 - Present