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Thomas Huang - Taiwan

Consultant, Quality and Regulatory Affairs

Thomas Huang joined the Emergo by UL consulting team in 2020, following several years as a UL Lead Auditor and Engineering Manager.

Thomas Huang joined the Emergo by UL consulting team in 2020, following several years as a UL Lead Auditor and Engineering Manager. His medical device background includes over 20 years of quality assurance and regulatory affairs experience within the industry, and deep knowledge of multiple device families. His main focus is on ISO management systems and US/EU regulation consulting. Thomas has acquired extensive experience regarding ISO 60601-1 reviews, 510(k) third party reviews, technical file compilations and acts as a Lead Auditor for ISO 9001 & ISO 13485, European Medical Device Directive (MDD) as well as against Medical Device Regulations (MDR), INMETRO and MDSAP requirement

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