プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Neethu A.に依頼

India

Medical Device Regulatory Specialist - U.S. FDA, 510(k), Specialized at Polymer glove 510(k) documentation

プロフィール概要

Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investigate, document, analyze, and provide resolution for any regulatory compliance concerns that arise. Expertise in Technical Documentation for 510(k) and EU-MDR. SKILLS: • 510(k) Classification-513(g), product codes, regulation • FDA Pre Submission: Documentation and provides regulatory opinions for Traditional/ Abbreviated/ special category • 510(k) Technical Documentation: Traditional, and Abbreviated. Ensure all regulatory data and documents are compliant with FDA, Performance Test Requirements, Predicate Device Identification. • Labelling: Review labels, labeling, and promotional materials for compliance with applicable regulations and policies. • Technical File: Documentation as per EU-MDR for Class I, IIa, IIb, and III. Ensure all regulatory data and documents are compliant with EU-MDR. • Risk Management: Risk management procedure, Plan, analysis, estimation, report, and risk-benefit analysis • CER: Clinical Evaluation documentation and scientific literature search, development of protocols • Biological Evaluation: Procedures and documentation, Biological evaluation plan, report summary

専門分野

• ★ Premarket Notification/510(k) Submission
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Medical Device Regulatory Writing
• ☆ Technical & Scientific Writing

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Technical Writing

Research Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

職務経験

Medical Device Regulatory Specialist

I3C Global

8月 2018 - 現在

学歴

Applied Electronics

Anna University

6月 2010 - 6月 2012

Biomedical Engineering

Anna University, Chennai, India

9月 2006 - 6月 2010

認定資格

• 認定資格の詳細は未入力です。