プロフィール詳細

プロジェクトを作成

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Pragatheeshwaran N.に依頼

India

Four plus years of hands-on working experience in Medical device PMS complaints handling, vigilance and RPA (Uipath )

プロフィール概要

Experienced in Medical device Post Market Surveillance (PMS) and process improvement. Familiarity with USFDA (21CFR Part 820, 806 and 803), QMS (ISO 13485:2016), ISO 14971, Complaint management, Complaint investigation, Risk analysis, CAPA initiation Complaint closure and submission of MDR.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Product Design
• ☆ CAD & 3D Modeling

サービス

• Research
• Consulting
• Product Development

Research Market Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Product Evaluation, Prototyping

職務経験

Quality analyst engineer

Cyient Limited

5月 2022 - 現在

Quality analyst engineer - PMS

HCL Technologies Ltd.

4月 2018 - 5月 2022

学歴

B.E

Parisutham Institute of Technology and Science

8月 2013 - 6月 2016

認定資格

• 認定資格の詳細は未入力です。