プロフィール詳細

プロジェクトを作成

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Dr. Sonia C.に依頼

France

Research and development, product development, program management, ISO 13485:2016, Medical Devices, In-vitro diagnostic

プロフィール概要

I have been working for the health industry, In-vitro diagnostic and medical devices for over 20 years, mainly at R&D positions and always in strong interaction with other functions. Besides R&D director role I have been project/program director and more and more involved in QA/RA activities with evolving regulations in IVD and medical device Industry. Strong expertise in product development, project managemnt. Experience in start-up, mid-size and large companies

専門分野

• ☆ Microbiology
• ☆ Molecular Biology
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Project Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Market Research, Feasibility Study, Fact Checking, Gap Analysis, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Concept Development, Prototyping

職務経験

Founder and Owner

KREADYS

9月 2020 - 現在

学歴

PhD Microbiology

University Tours, France

10月 1992 - 1月 1996

認定資格

• Green Belt certification EU-MDR

  Easy Medical Devices

  1月 2022 - 1月 2022