プロフィール詳細

プロジェクトを作成

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Dr. Amin J.に依頼

Switzerland

Medical Device Regulatory Consultant | CER, MDR, Risk Management,

プロフィール概要

Biomedical Engineer (PhD) specializing in Medical Devices, Regulatory Writing, and Clinical Evaluation. Experienced in preparing CER, MDR‑compliant documentation, risk–benefit analysis, and systematic literature reviews. Research background in tissue engineering, biomaterials, and preclinical studies, with strong skills in producing clear, accurate, and high‑quality technical and scientific documents for regulatory and research needs.

専門分野

• ☆ Biotechnology & Bioengineering
• ☆ Tissue Engineering
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Health Risk Assessments
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Risk Management

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

Research Market Research, Scientific and Technical Research, Systematic Literature Review

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Cleaning

Product Development Material Sourcing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Islamic Azad University Central Tehran Branch

6月 2018 - 現在

CEO/Founder

Bmedco

11月 2015 - 現在

学歴

Biomedical Sciences

Islamic Azad University, Central Tehran Branch - Iran

9月 2019 - 11月 2023

認定資格

• Technical Supervisor of Medical Equipment Certificate

  Iranian Ministry of Health

  1月 2019 - 現在