Arlington, VA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is delighted to welcome the U.S. Food and Drug Administration as an official co-sponsor of its upcoming medical device standards conference, AAMI and FDA neXus 2024. The conference will feature a wealth of FDA experts alongside industry members and will focus on the latest information on medical device regulations and standards.

AAMI and FDA neXus will be held from February 20 to 23, 2024, at the Omni Shoreham Hotel in Washington, D.C. Jeffrey Shuren M.D., director of the FDA’s Center for Devices and Radiological Health, will deliver a keynote on February 20. FDA experts will also present on the following topics:

• The FDA’s new QSR and transition to ISO 13485, presented by FDA’s Keisha Thomas, supervisory consumer safety, and Kimberly Lewandoski-Walker, regulatory officer.  
• Real-world evidence and medical device safety, presented by Daniel Caños, director of the Office of Clinical Evidence and Analysis at CDRH.
• FDA’s collaboration with IMDRF, presented by Ken Cavanaugh, deputy office director of the Office of Health Technology.
• The FDA case for quality, delivered by Francisco Vicenty, FDA consumer safety officer.
• Total product lifecycle, presented by Linda Ricci, deputy director of the Office of Strategic Partnerships and Technology Innovation and Tammy Beckham, associate office director.
• Additional FDA speakers on pulse oximeters, FDA’s health equity priorities, the ASCA program, biocompatibility, eSTAR, and more.

The conference also features educational courses on industrial sterilization, quality systems, human factors, and other topics. Industry experts are also scheduled to speak on topics like sterile processing, industry standards and other technical areas. Industry speakers include:

• University of Utah instructor David Classen M.D., on AI implementation.
• Global perspectives on ethylene oxide sterilization, presented by Brian McEvoy of STERIS and Molly Story of Human Spectrum Design.
• Development of IFUs for sterilization, presented by Nupur Jain of Intuitive Surgical and Ralph Basile of Healthmark Industries.
• Cleaning validation processes, presented by Terra Kremer, director of microbiological quality at Johnson & Johnson.
• Other sessions on international standardization, AI/ML, and forthcoming guidance documents.

The AAMI and FDA neXus is the newest iteration of the International Standards Conference (ISC), a must attend for medical device regulators and industry members since 1991. AAMI’s Robert Burroughs, chief learning and development officer said, “We’re excited to bring the same focus from ISC to AAMI Nexus but will also cover material on standards application. Development, adoption, and now application of standards, neXus covers it all.”

Those interested in attending can find registration for the AAMI FDA neXus here. Press passes are available upon request. Questions? Reach out to aamievents@aami.org for question about registration, sessions, and course offerings, and dvisnovsky@aami.org regarding press access.