プロフィール詳細

プロジェクトを作成

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Edwin W.に依頼

United States

medical device design control, software validation, human factors and risk management consultant

プロフィール概要

Over 27 years experience in regulated industry, 12 years as a consultant. I have advised startups to Fortune 100 companies in the US, Germany, United Kingdom, Netherlands, Poland, Saudi Arabia and Canada. I specialize in design control, risk analysis, software validation, cybersecurity and Human Factors. Conduct webinars on 15 medical device topics and corporate training Certified by Lloyd's of London as a ISO 9000 Lead Auditor Member of Thomson Reuters Expert Witness network Owner of MedDeviceAdvisors, a company selling 83 easily editable SOP's (www.meddeviceadvisors.com) Experience includes Development Engineering (software controlled medical devices) to the Director level. 5 patents.

専門分野

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サービス

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職務経験

consultant

Consultant

5月 2008 - 現在

学歴

Bachelor Mechanical Engineering

NYU

1月 2020 - 1月 2020

MBA-Finance

Drexel University

1月 2020 - 1月 2020

認定資格

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