プロフィール詳細

プロジェクトを作成

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Eddie W.に依頼

Switzerland

10 year ex-Abbott RA/QA professional | Expert in ISO 13485, CE Marking, 510(k) and WHO PQ for MD and IVDs

プロフィール概要

I'm excited to help businesses reach market approval on their new or existing medical devices and IVDs. I have experience working with both small/medium enterprises as a supplier auditor, establishing ISO 13485 QMS in 500+ large organizations, and bringing devices to market at record speed.

専門分野

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Medical Equipment & Supplies

サービス

• Writing

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

職務経験

Sr. Manager Regulatory Affairs

Abbott Laboratories

1月 2015 - 7月 2025

学歴

Masters in Public Health

Emory University

9月 2012 - 5月 2014

Bachelors

Johns Hopkins University

9月 2009 - 5月 2012

認定資格

• ISO 13485 lead auditor

  bsi

  2月 2016 - 現在