Profile Details

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☆☆☆☆☆

USD 50 /hr

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☆☆☆☆☆

Hire Dr. Umadevi R.

India

USD 50 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• 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

Work Experience

Manager

Pharmalex India Pvt Ltd

January 2025 - Present

Education

PhD, Biochemistry

University of Madras

December 2007 - November 2012

Certifications

• Project Management

  PMI

  December 2024 - Present