プロフィール詳細

プロジェクトを作成

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Nida A.に依頼

Pakistan

Experienced MDR and FDA certified CER/Technical File Writer with 7+ years of experience with multinational industries

プロフィール概要

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/745, EU IVDR 2017/746, ISO-10993-1:2021, and FDA compliance. Provided strategic support in regulatory affairs, post-market product surveillance, and quality assurance in CE marking of EU Class I, IIa, IIb or III medical devices by writing Clinical Evaluation Reports (CERs) providing clinical evidence of the device's state of the art for medical treatment and its safety and performance and response to notified body feedback. I would be eager to consult on new projects moving forward. I have worked with companies in USA (Shukla Medical, Ride Design, Mobility Research etc.) and in Europe (Stanpharma, RenovoDerm, AndraMed, AndraTec etc.). I have successfully achieved approval of my documentation from Notified bodies and even FDA. I prepare CERs, BERs, Design Dossiers, Technical Files, Risk Management Documents ISO 14971, Quality System ISO 13485 and ISO 9001 documentation including quality manuals, quality policy and SOPs.

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ Regulatory Writing
• ★ Clinical Evaluation Reports (CER)
• ☆ Microbiology
• ☆ Clinical Microbiology
• ☆ Drug Development
• ☆ In vitro Preclinical Toxciology
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ Regulatory Affairs
• ☆ Medical Sciences
• ☆ Research Methodology
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Research Summaries & Abstracts
• ☆ Cochrane Reviews
• ☆ Medical Copywriting
• ☆ Technical & Scientific Writing
• ☆ White Papers
• ☆ Literature Review
• ☆ Systematic Literature Review

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Creative Writing

Research Feasibility Study, Technology Scouting, Fact Checking, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis, Image Processing, Image Analysis, Algorithm Design-Non ML, Algorithm Design-ML, Data Visualization, Big Data Analytics, Text Mining & Analytics, Data Mining

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping, Reverse Engineering, Device Fabrication

職務経験

PRRC & Regulatory Advisor

Healthy Stuff Online

10月 2022 - 現在

Director Technical Evaluation

Kounter Intuitive technology

6月 2014 - 現在

Director (Technical Evaluation)

Kounter Intuitive Technologies

3月 2014 - 現在

学歴

Law (LLB Honours)

London School of Economics and Political Science, University of London

1月 2005 - 1月 2008

A-levels

Roots College International

5月 2004 - 5月 2006

認定資格

• ISO 14971:2019

  SGS

  12月 2022 - 現在

• ISO 13485 lead auditor

  SGS

  3月 2020 - 現在

• ISO 9001: Lead Auditor

  SGS

  1月 2019 - 現在

• MDR lead Auditor

  SGS Belgium

  5月 2017 - 現在

出版物

WEBSITE

Nida Ali (2023). Food Allergy Laws in Restaurants in the UK . LifeLabtesting.

Nida Ali (2023). Non-Coeliac Gluten Sensitivity (NCGS) . LifeLabTesting UK.