Hui Min Tan
Quality Assurance/ Regulatory Affairs Manager
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About
I register medical devices for IVD DIRECTIVE 98/79/EC and Regulation (EU) 2017/745 for their distribution with the European Union Notified Bodies (EU NB).
I also build, implement and maintain the quality management system for medical devices system and obtained certification for ISO 13485:2016 and EN ISO 13485:2016.
Experience
I build, implement and maintain the quality management system for medical devices system and obtained certification for ISO 13485:2016 and EN ISO 13485:2016. As a certified ISO 9001:2015 Lead Auditor and certified ISO 13485:2016 Internal Auditor, I prepared and reviewed standard operating procedures for both internal and external audits. I maintained compliance with the requirements of GDPMDS SS620:2016 for distribution of medical device in Singapore.
I register medical devices for IVD DIRECTIVE 98/79/EC and Regulation (EU) 2017/745 for their distribution with the European Union Notified Bodies (EU NB).
Education
Nanyang Technological University,
Bachelor of Engineering (Honours (Merit)), Bioengineering 2016 – 2020
