Medical device regulation Affair Specialist
About CHUN-YI CHEN:
MSc Bioengineering student at University of Nottingham with experience working in the medical device industry, with an emphasis on navigating EU MDR regulations, ISO13485 and QSR 820.
- To make the validation master plans for class IIa and class Im devices. And, discuss the testing conditions with testing laboratories like SGS and UL.
- Cooperated with quality assurance and quality control departments to monitor IQC, OPQC, PQC, FQC, OQC’s data to ensure the device’s quality. Use 5 Why and Fishbone methods to do the Corrective And Preventive Action when there was a complain event which needs to be analyzed.
- Manage the whole PMS system and re-write the PMS process in our company to fulfill the requirements with MDR regulation.
University of Nottingham Master's degree, Bioengineering and Biomedical Engineering · (August 2023 - September 2024)
Tzu Chi University Master's degree, Department of Laboratory Medicine and Biotechnology · (July 2017 - July 2018)
Tzu Chi University Bachelor's degree, Life Science · (September 2013 - July 2017)
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