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Transitioning from EUA to 510(k) for IVD Products: Planning to Execution

Online Event

In 2020, NAMSA hosted, “Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect?,” which focused on necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval. Two years later, we all have a stronger understanding of the expiration timeline for the Emergency Use Authorization (EUA) and a clearer picture of how to prepare for the upcoming changes. NAMSA invites you to attend this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to achieve a quick and timely 510(k) approval.

Founders Unfiltered: A Conversation with Afif Ghannoum, co-founder of BIOHM Health.

Online Event

Join JumpStart for the next episode of Founders Unfiltered featuring Afif Ghannoum, co-founder of BIOHM Health. Afif, a biotechnology attorney by training, co-founded BIOHM with his father Dr. Mahmoud Ghannoum, a global leader in medical mycology and Case Western Reserve University Professor. The father and son duo launched BIOHM in 2016 to help bring Dr. Ghannoum’s science to consumers, commercializing probiotics and microbiome testing kits to target fungi and bacteria in the digestive tract. JumpStart will talk to Afif about BIOHM’s recent funding round, the results of their groundbreaking clinical trials and his work commercializing healthcare innovation.

MedCon Conference 2022

Online Event

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.

Virtual Medtech Happy Hour

Online Event

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.

14th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistics Issues Conference

Online Event

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

2022 Harrington Discovery Institute Virtual Scientific Symposium

Online Event

Harrington Discovery Institute accelerates promising discoveries into medicines for unmet needs focusing on Major Diseases, Brain Health Medicines, COVID-19, and Rare Diseases. Our work endeavors to improve human health and better our world. We are driven by passion, innovation, and integrity, to cure diseases together.

The Basics of IVDR Clinical Studies, a NAMSA webinar

Online Event

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.

Building Great Teams with Stock Plans

Online Event

Most start-up founders and investors agree that stock plans are an important tool to build great teams and retain talent. However, implementing an employee stock plan can be expensive, time-consuming, and confusing. Many founders delay using employee stocks or don't implement plans properly, which can result in team confusion instead of engagement. Join Taft partner Matt Secrist, Cake Equity co-founder Jason Atkins, and Lazurite president and general counsel Leah Brownlee for this webinar as they discuss how to get the most out of employee stock plans.

Navigating Military Medical Conference, DoD & Funding Opportunities

Online Event

Join G2G for insights into preparing for and maximizing participation in the MHSRS conference, plus tips on navigating and engaging effectively with the Defense Health Agency, Futures Command, USAMRDC, WRAIR, USAISR and other potential collaborators within government.

Virtual Medtech Happy Hour: Preparing for the Valley of Death

Online Event

Grab your favorite drink (or just a drink), come learn and interact with industry experts while they discuss hot topics in Medtech. Speaker: Dr. Wessels founded LiquidSMARTS℠. He leads the global practice and is a member of the leadership team. He is passionate and dedicated to the improvement of human performance and ethical business practices in sales and marketing. His expertise comes from more than 25 years in the healthcare industry, including 14 years as a consultant to global and local marketing and sales teams. His clients gain rapid performance improvement through analysis, design, implementation of market approach, and commercial operations execution. He leads the field in providing micro-learning for business professionals. His micro-learning approach teaches people essential soft-skills and influencing and leadership behaviors in a few minutes per day.