Ye-Lynne Lee

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Consultant
Ye-Lynne Lee is a Consultant in quality, regulatory, and vigilance of medical devices. She completed her pharmacy degree and graduated with a masters in medical devices, focusing her training on Regulation (EU) 2017/745. She has expanded her expertise to medical device quality and vigilance. She now works with medical device companies and occasionally lectures in masters’ programs.

Related Articles

Medical Device UDI Components Management in the European Union
Technical
Medical Device UDI Components Management in the European Union

Since 2019, the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the article.