Profile Details

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USD 125 /hr

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Hire Edwin W.

United States

USD 125 /hr

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

Profile Summary

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.

Subject Matter Expertise

• Expertise details not provided.

Services

• Services details not provided.

Work Experience

consultant

Consultant

May 2008 - Present

Education

Bachelor Mechanical Engineering

NYU

January 2020 - January 2020

MBA-Finance

Drexel University

January 2020 - January 2020

Certifications

• Certification details not provided.