A recently introduced set of medical device regulations calls for more thorough chemical testing for extractables and leachables and the establishment of robust risk-management processes aimed at enhancing patient safety. In complying with these new regulations, medical device manufacturers must carefully consider technologies and value-adding solutions that support an uninterrupted and accelerated route to market, including application of quality management software, improving data integrity, and leveraging modern instrumentation to gain greater insight into chemical and material characterization.
Join the discussion and hear first-hand how industry experts have built effective and compliant risk-management workflows that help smooth the path of medical device product to market.
Comprehensive chemical characterization of a medical device for biocompatibility is an analytical challenge. New regulations specify that all compounds above the analytical evaluation threshold must be identified.
Presenter: Sarah Dowd, Ph.D. (Senior MS Application Specialist, Waters Corporation)
Sarah Dowd has been working as a senior MS application specialist for Waters corporation since receiving her Ph.D. in analytical chemistry from the University of Illinois at Urbana Champaign. While working in the mass spectrometry applications lab, she has done extensive work on chemical materials applications with both tandem quad and high-resolution mass spectrometers. In her five years at Waters, Sarah has collaborated with many customers looking to expand the MS capabilities of their laboratories with Water's instruments and software.
