The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Health’s legacy of delivering the MedCon Conference.
Innovation: Setting your Company Up for Success in Commercialization, Adoption, and Further Investment. Presented by Project Medtech, this online event features speaker Kipum (Kip) Lee, a designer, scholar, and healthcare executive. Currently, he serves as Vice President of Innovation & Product Strategy at University Hospitals (UH) in Cleveland, OH where he leads a team of innovators within UH Ventures – the innovation and commercialization arm of health system. His day-to-day work involves managing the innovation portfolio and "living lab" that supports University Hospitals’ strategic initiatives and partnerships through product innovation and human-centered design. Earlier in his career, he was part of the team at frog design that produced a mobile service around HIV awareness and self-testing in South Africa that was hailed by The Economist as “the world’s largest field trial in mobile health technology.” He also helped plan and lead the design of Marriott Mobile, which debuted at number four in the iTunes App Store and shortly went on to become the third-largest in mCommerce after Amazon and Apple.
This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. In an effort to provide quality programming in the safest and most effective manner possible, the Conference will once again be held virtually this year. Dates: Wednesday, May 11th - Friday, May 13th
Join NAMSA for this webinar as we walk through the key differences between EU’s In Vitro Diagnostic Directive (IVDD) and IVDR and the clinical study requirements outlined within these regulations. We will also examine ISO 20916:2019 as the Good Clinical Practice (GCP) guidance for IVD clinical performance.