プロフィール詳細

プロジェクトを作成

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Biomedical E.に依頼

Pakistan

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience

プロフィール概要

Myself Umair Ahmed, a Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical device consultation. My expertise lies in regulatory affairs, quality assurance, and technical documentation within the medical device industry. My freelance services cover a wide range of areas, including global regulatory strategy, quality systems development, risk management, and submission processes. I am well-versed in FDA Quality System Regulations, EU Medical Device Regulation (MDR), and relevant ISO standards. • Experienced clinical research and medical device Technical file writer • Expert In: • EU MDR xxxxxxxx • EU IVDR xxxxxxxx • FDA compliance • SFDA • UK MHRA I can assist you in : • Technical Documentation under EU MDR/ EU IVDR/ FDA/ MHRA/ SFDA • Clinical Evaluation Reports (CERs) to provide clinical evidence of device's state of the art, safety, performance, and response to notified body feedback • Biological Evaluation Reports according to ISO 10993-1 to 23 • Quality Manuals according to ISO 13485 What you will get from me: • Preparation 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. • On time delivery • Best Results with 100% Approval surety ISO Standards on that I have worked on: • ISO 13485 • ISO 14971 • ISO 10993-1 • IEC 60601 • IEC 62304 • EU MDR xxxxxxxxxxxxx CFR 820.198 • FDA 21 CFR Part 820 Quality System Regulations • 21 CFR Part 11 Electronic Records • cGXP (GLP, GMP) I have created Multiple Technical Documentation according to MEDDEV 2.7.1 Rev.4 and then updated it to MDR (EU) xxxxxxxx. The following Documents will be Provided under MDR in my service plan Declaration of Conformity Design & Manufacturing Information General Safety & Performance Requirements Harmonized Standard Compliance Risk Management Plan Risk Management Report Verification & Validation Report Post Market Surveillance Packaging & Labelling CER Plan. Undertaking. Technical File Summary CER (Clinical Evaluation) BER (Biological Evaluation) IFU

専門分野

• ☆ Biotechnology & Bioengineering
• ☆ Biomedical Engineering
• ☆ Biological Engineering
• ☆ Medical Devices
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Healthcare Quality Improvement
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Software QA & Testing
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Clinical Trial Documentation
• ☆ Clinical Study Reports
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ White Papers

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, General Proofreading & Editing, Translation

Research Market Research, User Research, Meta-Research, Feasibility Study, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Healthcare Consulting, Legal Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis, Image Processing, Image Analysis, Data Visualization, Data Cleaning, Data Processing

Product Development Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Packaging Design

職務経験

Assistant Manager QC

NUST

9月 2019 - 現在

Medical Device regulatory Affairs Consultant | QA/QC Engineer | Biomedical Engineer

Upwork

1月 2018 - 現在

学歴

Biomedical Engineer and Sciences (Biomedical)

National University of Sciences and Technology

9月 2018 - 10月 2020

MS Biomedical Engineering

National University of Science & Technology (NUST)

9月 2018 - 1月 2020

認定資格

• ISO 13485

  SGS

  1月 2020 - 現在

• EU MDR Technical Documentation

  SGS

  1月 2019 - 現在

出版物

CONFERENCE PAPER

Ahmed, U., Rasool, G., Zafar, S., & Maqbool, H. F. (2018, November). Fuzzy rule based diagnostic system to detect the lung cancer. In 2018 International Conference on Computing, Electronic and Electrical Engineering (ICE Cube) (pp. 1-6). IEEE .