August 25, 2024
Gradient will exhibit at MEDevice Boston September 25-26, 2024, in booth number 523 (Exhibit Level Hall C).
Our team will co-present with Eurofins EAG Laboratories in the MEDevice Tech Theater at 10:30am ET on September 25.
Presentation Title: Biocompatibility Strategies for Saving Cost and Time When Making a Change to Your Device
Abstract: Material supplier and specification changes during initial and re-assessment of design verification biocompatibility activities can present an additional hurdle for manufacturers, which can result in costly and time-consuming retesting. In this presentation, we discuss how to evaluate biocompatibility material equivalence through leveraging physical and chemical characterization strategies. We incorporate ISO 10993-19 physical, morphological, and topographical (PMT) characterization to reduce the burden of retesting while ensuring enough information to evaluate device safety. Further, we will explain approaches leveraging targeted chemical characterization for equivalency and toxicological risk assessment of extractable chemicals.
Speakers include Drs. Alex Gauthier and Joel Cohen from Gradient and Drs. Todd Stark and Saheel Bhana from Eurofins EAG Laboratories.
View more information about our joint presentation or contact us to learn more about medical device services.