プロフィール詳細

プロジェクトを作成

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Dr. Sheraz Hussain S.に依頼

Pakistan

Medical device regulations EU MDR 2017/745,Clinical evaluation ,ISO 13485 AND validation expert

プロフィール概要

1.Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive (MDD). 2.Preparation of complete technical file CE marking. 3.Preparation of ISO 13485 DOCUMENTS and help in achieving certification 4.Conducting risk management and analysis in accordance with ISO 14971. 5.Prepare validation plan and IFU for device 6.Help organization to get 510k for medical device

専門分野

• ★ Medical Devices
• ★ Regulatory Writing
• ★ Clinical Study Reports
• ☆ Product Compliance

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research User Research

Consulting Scientific and Technical Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Concept Development

職務経験

Senior Consultant Regulatory affairs

Quick Busines

1月 2013 - 現在

学歴

Doctor in Dental Sciences

Punjabi University

4月 2008 - 1月 2013

認定資格

• iso 14971

  TUV

  11月 2017 - 現在

• ISO 13485

  IRCA

  1月 2017 - 現在