Northwestern Events Calendar


Navigating the Medical Device and Diagnostic Regulatory Environment | A Perspective from Abbott Leaders

When: Tuesday, April 23, 2024
12:00 PM - 1:00 PM CT

Where: Online

Audience: Faculty/Staff - Student - Post Docs/Docs - Graduate Students

Contact: Sonia Kim   (847) 467-0446

Group: Innovation and New Ventures Office

Category: Academic, Lectures & Meetings


Explore the landscape of global regulatory frameworks and strategic considerations pivotal in bringing a new medical device or in vitro diagnostic product to market.  Caroline Mendes and Rodney Huang will discuss how to identify the applicable regulatory requirements for a new IVD or medical device, considerations in Pre-Submissions to the FDA, and additional Regulatory requirements that are critical to know early in the product development process. 

This talk is for everyone who may be interested in new product development in the healthcare industry and wants to understand the general process of getting a new product authorized to be commercialized in a regulated market.

Northwestern Univ can register here

NM/SRAL/Lurie Children's/NU Startups can register here:



Caroline Mendes (Principal Specialist, Regulatory Affairs, Abbott Core Diagnostics) joined Abbott in 2018 as a Scientist based in Ireland, and in 2022 she joined the Regulatory Affairs Organization and moved to the U.S. (Lake County).  Currently, she is part of the New Product Development team and supports the development of in vitro diagnostic products for infectious diseases and clinical chemistry, helping to outline global regulatory strategies, providing regulatory inputs to product development, and working on regulatory submissions.  Caroline has a Ph.D. in Biological Sciences from Technological University Dublin. 

Rodney Huang (Director, Regulatory Affairs, Abbott Diabetes Care) joined Abbott in 2011 and has played a key role in bringing the FreeStyle Libre family of continuous glucose monitoring systems to the US market. Developing robust regulatory strategies and building FDA relationships were essential to successfully navigating the evolving regulatory landscape.  Rodney holds bachelor's degrees from the Massachusetts Institute of Technology in biology and electrical engineering / computer science and a master's degree from the University of California, San Diego in bioengineering.

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