Evangeline Loh

An exuberant advocate for the regulatory harmonization of medical devices, Evangeline Loh leads the team of international consultants at Emergo by UL in regulatory affairs and quality. She brings more than 20 years of global regulatory experience, with specialties in European market access and compliance, global regulatory affairs requirements, post-marketing surveillance and vigilance, and global regulatory strategy.

Global Regulatory Strategy

A recognized expert in global medical device regulatory developments and with a specialization in European Union (EU) regulatory matters, Evangeline guides the Emergo by UL consulting team in developing thought leadership in global regulatory strategy. She works closely with the team to prepare global regulatory assessments for medical devices on behalf of customers. Concerning global vigilance, Evangeline and her team assist medical device manufacturers in the requirements of field safety corrective action or recalls as necessary. She speaks at regulatory conferences worldwide and is widely published in journals involving in-country and global medical device regulatory matters. An assistant professor at the University of Georgia’s College of Pharmacy Department of International Biomedical Regulatory Sciences (IBRS), she teaches a graduate course on global medical device regulations.

EU Clinical Evaluation

Evangeline brings a wealth of experience involving clinical research, trials and analysis skills as she leads clinical evaluation plans and reports and advises medical device manufacturers on their responses to notified bodies. This includes helping manufacturers identify the state of the art for their device and establishing appropriate clinical performance outcomes. She has presented and contributed her thought leadership at many conferences on topics that include clinical evaluations, EU Medical Device Regulation (MDR) compliance and other EU regulatory matters.

“Regulatory strategy is a critical, early step in planning your global medical devices’ success. Given the evolving standards and complex requirements, a proactive and well-designed approach can enable innovation, streamline market access and position your business for sustained growth.” – Evangeline Loh

Panels and boards

• Regulatory Affairs Certification (RAC); U.S. received 2005, EU received 2006
• Committee member (2021), Asia Pacific Economic Cooperation (APEC) – University of Southern California (USC) Program Committee
• Committee member (2021), Green Light Guru Regulatory Advisory Board (RAB)
• Jury member (2024), 16th Healthcare Innovation World Cup, Innovation World Cup Series

Connect with Evangeline Loh

LinkedIn

Within UL Solutions we provide a broad portfolio of offerings to many industries. This includes certification, testing, inspection, assessment, verification and consulting services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL Solutions has processes in place to identify and manage any potential conflicts of interest and maintain the impartiality of our conformity assessment services.