Early product development planning is a critical time for medical device manufactures, as decisions made during this process can affect timelines and budgets. NAMSA understands first-hand the intricacies of models and testing methods, along with the ultimate goal of successful regulatory review and approval, to move on to clinical trials.
Join us for our webinar, presented by preclinical expert Mark Smith (NAMSA’s Strategic Advisor for Laboratory and Consulting), 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.
We will also review key steps in the project development pathway—from a novel solution to address an unmet medical need through to approval for first-in-human trials—and provide best practices on how to avoid the traps and pitfalls that can unexpectedly derail or significantly delay a project.
Attendees can expect the following topics to be addressed throughout the webinar:
- Overall Processes in Discovery and Product Concept Identification for Medical Devices
- Main Issues in the Primary Areas of Cardiovascular Device Utilization
- Highlights of U.S. FDA Guidance for Preclinical Testing of Class III CV Medical Devices
- Key Learnings to Enhance the Regulatory Success of Pivotal GLP Safety Studies