プロフィール詳細

プロジェクトを作成

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Dr. Umadevi R.に依頼

India

Writing...! for life/biology....for sciences....for medical devices...!

プロフィール概要

A Seasoned Medical Writer and Regulatory Affairs professional with a Ph.D. and extensive expertise in authoring high-impact clinical and regulatory documents for IVDR/MDR compliance for In vitro diagnostics (IVDs), medical devices and clinical services.

専門分野

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices

サービス

• Writing
• Research
• Consulting

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

職務経験

Manager

Pharmalex India Pvt Ltd

1月 2025 - 現在

学歴

PhD, Biochemistry

University of Madras

12月 2007 - 11月 2012

認定資格

• Project Management

  PMI

  12月 2024 - 現在