プロフィール詳細

プロジェクトを作成

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Prafullakumar P.に依頼

India

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

プロフィール概要

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

専門分野

• ☆ 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

サービス

• Writing
• Consulting

Writing Technical Writing

Consulting Regulatory Consulting

職務経験

Regulatory Expert

VREG SOLUTIONS

2月 2025 - 現在

RA/QA MANAGER

Maven profcon

7月 2021 - 2月 2025

学歴

Masters of Science-Medical Device

National Institute of Pharmaceutical Education and Research

6月 2019 - 4月 2021

認定資格

• Certified Internal Auditor

  TNV

  1月 2023 - 現在