Profile Details

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USD 30 /hr

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Hire Biomedical E.

Pakistan

USD 30 /hr

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

Profile Summary

I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical device consulting sphere. 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 • MDCG guidelines EU • MDRMEDDEV 2.7/1 • FDA compliance • SFDA • UK MHRA I can assist you in : • Technical Docuemntation 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 xxxxxxxxxxxxx • Quality Manuals according to ISO xxxxxxxxxx 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 SO Standars on that I have worked on: • ISO xxxxxxxxxx • ISO xxxxxxxxxx • ISO xxxxxxxxxxxx • 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

Subject Matter Expertise

• ☆ 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

Services

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

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

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, Manufacturing Consulting

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

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

Work Experience

Assistant Manager QC

NUST

September 2019 - Present

EU MDR CER Writer

Upwork

January 2018 - Present

Education

Biomedical Engineer and Sciences (Biomedical)

National University of Sciences and Technology

September 2018 - October 2020

MS Biomedical Engineering

National University of Science & Technology (NUST)

September 2018 - January 2020

Certifications

• ISO 13485

  SGS

  January 2020 - Present

• EU MDR Technical Documentation

  SGS

  January 2019 - Present

Publications

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 .