プロフィール詳細

プロジェクトを作成

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Ashwini L.に依頼

Netherlands

Quality Management System, Risk Assessment, Post Market Surveillance, Lead Auditor ISO 13485, Compliance Expert

プロフィール概要

Over 15 years of experience in Quality and Regulatory Affairs, Risk Assessment, Verification, and Validation, of medical devices like Patient Monitoring and Central Nursing Station. Prepared and finalized technical files for CE Marking (MDD & MDR) marking of Class IIa, and IIb devices including all follow-ups and questions from Notified Bodies. Responsible for authoring 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, Verification, Validation) Expertise in IEC xxxxxxxxxx & AAMI EC13 ( BASIC SAFETY and ESSENTIAL PERFORMANCE of ECG MONITORING EQUIPMENT ), IEC 62366 (Usability Engineering), IEC 62304 (medical device software – software life cycle processes), Total Expertise in the application of EU MDR 2017/745, ISO 13485 (certified lead Auditor), ISO 14971, FDA 21 CFR Part 820,21 CFR 822 standards. Well-versed in the development of Quality Plan, Risk Management Plan & Report, DFMEA, Regulatory Files, POst MarketSurveillancePlan & report, Verification Plan & Report, Validation Plan & Report, CAPA, literature searches, clinical evaluations report as per MEDDEV 2.7.1 rev.4, predicate device comparisons, development of SOP's and other QMS documentation.

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Risk Management
• ☆ Regulatory Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Market Research, Feasibility Study

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Stability/Shelf Life Testing, Product Validation, Prototyping

職務経験

Verification and Validation Lead

Bambi Medical

10月 2018 - 2月 2022

Technical Specialist

UST Global

7月 2017 - 9月 2018

Technical Lead/Consultant

Wipro Technologies

3月 2012 - 7月 2017

Senior Quality Specialist

Larsen and Toubro Limited

2月 2007 - 2月 2012

学歴

Bachelors

Technical University

6月 2002 - 7月 2005

認定資格

• Lead Auditor

  bsi

  2月 2020 - 現在