Join our Presentation
Title: Designing Effective E&L Studies for Cardiovascular Medical Devices: From Study Planning to Troubleshooting
Presenter: Alexa McLean, Expert Technical Consultant, Nelson Labs
Location: Innovation Spotlight Theater (756)
Day & Time: Wednesday, November 18th 1:30pm – 2:15pm
Abstract:
Extractables and Leachables (E&L) testing can present unique challenges for cardiovascular medical devices, where complex designs and diverse materials must be considered when developing an appropriate testing strategy. This presentation will explore key elements of E&L study design, including defining study objectives, selecting representative materials and components, establishing appropriate extraction conditions, and developing analytical strategies that generate meaningful and defensible data.
Real-world case studies will illustrate challenges encountered during testing and the troubleshooting approaches used to investigate unexpected findings, analytical issues, and other study complications. Attendees will gain practical insights to help bridge device development with regulatory expectations and improve overall E&L study planning.
Alexa McLean
Alexa McLean has been a member of the Analytical Chemistry team at Nelson Labs for the past 17 years. After earning her degree in Microbiology, she began her career in the Chemistry laboratory at Nelson Labs, where she has played an integral role in the development and growth of the company’s Extractables and Leachables (E&L) testing program since its inception.
Alexa served as an E&L Study Director for more than 10 years and currently works closely with Sponsors to design and develop testing strategies for E&L projects at Nelson Labs’ Salt Lake City facility. She also provides support to Sponsors throughout the regulatory submission process.
Alexa is an active member of AAMI BE-WG14, the working group responsible for standards related to Chemical Characterization testing.