Clinical Challenges Under the EU MDR

Online Event

With the EU Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR, and introducing new products. Although the Medical Device Coordination Group (MDCG) guidance has been forthcoming, there remain significant gaps in guidance and interpretation of requirements, and varying interpretations of expectations. In addition with the limited number of Notified Bodies designated under the MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024. NAMSA invites you to join this upcoming webinar as our team of regulatory experts discuss practical insights to address these challenges.

The Conference on Innovations in Climate Resilience

Columbus, OH

The Conference on Innovations in Climate Resilience, presented by Battelle in collaboration with DOE National Laboratories, offers a curated technical program with invited keynote presentations, platform and lightning talks and a poster reception. We’re expecting an audience of government leaders, entrepreneurs and innovators to explore breakthroughs in technology, science, policy and infrastructure that will help mitigate the threats to our environment, health, communities, national security and economic well-being from a changing climate.

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.

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

Building the Future: Ohio’s Commitment to Cell & Gene Therapy

The Athletic Club of Columbus OH

ARM, in partnership with BioOhio and JobsOhio, will hold its first state event in Columbus in May, showcasing Ohio’s leadership in creating a hub for the cell and gene therapy field. The event will include a panel discussion from 4:00 pm - 5:00 pm, followed by a reception from 5:00 pm - 7:00 pm.

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.

Ohio Life Sciences Networking Social in Cleveland

Saucy Brew Cleveland

Join BioOhio and Project Medtech for a fun networking social in Cleveland, Ohio! This event will bring the region's life science community together for networking and connecting. We'll be at local gem and member Saucy Brew!

Webinar: Chemical Characterization Best Practices – Assumptions of TTC and Exhaustive Extraction

Online Event

A dramatic shift in regulatory opinions has occurred within the last several years regarding the concepts of Extractables and Leachables (E&L) testing of medical devices, commonly known as Chemical Characterization. Much of that change was driven by the 2020 revision to ISO 10993-18. Join NAMSA for this webinar to learn more about the foundations behind Chemical Characterization and to examine best practices deriving from it.