蘇耿民 Andy Su

Andy Su has had a varied work experience in the medical device field. From 2015 to 2016, they were a Sales Representative for BIOTRONIK. From 2016 to 2017, they were a RA/QA for Acute Ideas Co. Ltd./ Rumble Tuff, where they built up, maintained, and improved ISO 13485:2016 quality system and submitted an FDA class II MD application. From 2017 to 2020, they were a Consultant for SOHO, specializing in ISO 13485/GMP and MDD. In 2018, they were a Regulatory Affairs Specialist for Industrial Technology Research Institute (ITRI). Finally, from 2020 to present, they have been a Senior Engineer/PM for Flat Medical, Inc., where they are responsible for MDR build up and ISO13485/GMP renewal.

Andy Su obtained their Bachelor's Degree in Life Science from National Yang Ming University between 2009 and 2013. 蘇耿民 then earned their Master's Degree in Biomedical/Medical Engineering from the same university between 2013 and 2015. Additionally, they obtained an ISO13485:2016 Internal Auditor certification from DNV GL in December 2016, and they are also certified with TOEIC.