Profile Details

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USD 335 /hr

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Hire Dr. Sheraz Hussain S.

Pakistan

USD 335 /hr

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

Profile Summary

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

Subject Matter Expertise

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

Services

• 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

Work Experience

Senior Consultant Regulatory affairs

Quick Busines

January 2013 - Present

Education

Doctor in Dental Sciences

Punjabi University

April 2008 - January 2013

Certifications

• iso 14971

  TUV

  November 2017 - Present

• ISO 13485

  IRCA

  January 2017 - Present