In this free, in-depth webinar, Satyajit ‘Sat’ Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and mechanical life cycles, to provide consistency for process elements like Requirements, Risk Analysis, Failure Mode Analysis Architecture, Design, Implementation, Test, Traceability as well as consistency in language, i.e Items, Units. Participants will learn how to apply these principles to the entire medical device life cycle, leading to more efficient design, development and manufacturing.

Join us for this webinar as we discuss strategies to optimize your preclinical testing with an emphasis on complex Class II and Class III medical devices focused in the cardiovascular therapeutic area. Highlighted will be an overview of cardiovascular device conceptualization, prototype and iterative design, model selection and how to build a foolproof pivotal safety-testing plan.