AAMI neXus will spotlight the standards and regulatory shifts shaping how clinical engineers manage technology.
By Alyx Arnett
The standards and regulatory conversations shaping clinical engineers’ day-to-day work take center stage at AAMI neXus this month in Leesburg, Va.
While the event largely draws device manufacturers, regulators, and sterilization professionals, it also offers a window into the decisions that increasingly influence how clinical engineers manage technology in hospitals.
Danielle McGeary, vice president of HTM at AAMI, says neXus provides a different kind of value than AAMI eXchange, which is the primary AAMI event for HTM professionals. “The AAMI neXus has a great deal of content and programming that would be useful for clinical engineers whose work applies to medical device design or whose work applies to design standards or regulatory requirements,” McGeary says.
neXus 2026, scheduled for April 14–17, will cover topics ranging from US Food and Drug Administration (FDA) regulatory priorities and global standards alignment to artificial intelligence (AI), cybersecurity, and sterilization. Sessions will examine issues such as predetermined change control plans for AI, managing bias in machine learning systems, preparing for emerging cyber threats, and the push toward “regulatory-ready” standards.
One session, The Future of Healthcare: Toward a Fully Integrated, Continuously Learning System, will bring together leaders from across industry and government to explore how emerging technologies—and the standards behind them—are reshaping care delivery.
Among the panelists is Jesse M. Ehrenfeld, MD, MPH, global chief medical officer at Aidoc, chair of IEC TC 62, and professor at the Medical College of Wisconsin, who says the dominant theme driving current standards discussions is convergence.
“In the past, we could silo hardware, software, and electrical safety,” Ehrenfeld says. “Today, those lines are totally gone.”
“We are moving toward a world where a device is actually a node in a massive interconnected clinical network,” he adds, noting that standards are shifting to protect that broader ecosystem.
The program will also feature presentations from federal regulators, including Michelle Tarver, MD, PhD, who will speak on how regulations and standards intersect in ensuring device safety. For some current and former FDA officials, the event will mark their first public remarks since the new administration took office.
Registration information is available on AAMI’s website.
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