The Association for the Advancement of Medical Instrumentation (AAMI) announced that it will host AAMI neXus: The Medical Device Standards Conference, an event covering health technology standards and regulatory requirements for the medical device sector.
Held from February 20-23, 2024, at the Omni Shoreham Hotel in Washington, D.C., AAMI neXus takes the place of the International Standards Conference (ISC). Since 1991, ISC was a conference for industry and regulatory leaders involved in the development and adoption of medical device standards. AAMI neXus features ISC’s previous programming but includes a new focus on applying medical device standards.
“We’re excited to bring the same focus from ISC to AAMI neXus but to add material on standards application, Robert Burroughs, AAMI chief learning and development officer. “AAMI neXus will address the development, adoption, and application of industry standards.”
New sessions and training will tackle how industry professionals can develop, adopt, and apply standards and regulations. This will include deep-dive symposia on new regulatory changes and developments and ‘101-level’ bootcamps for those new to the industry or a particular technical area.
Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at FDA, will deliver the keynote on the first day of AAMI neXus. The complete program of sessions, events, and workshops will be released in November. Issue areas addressed at AAMI neXus will include:
- FDA developments related to Accreditation Scheme for Conformity Assessment (ASCA) and electronic Submission Template and Resources (eSTAR).
- FDA’s switch to ISO 13485 and implications for the medical device industry.
- Updates on the FDA case for quality and the Voluntary Improvement Program.
- Global markets and regulations in the European Union, Asia, Latin America, Africa, and elsewhere.
- Industrial sterilization, biocompatibility, and combination products.
- New and emerging issues like cloud computing, AI, and cybersecurity threats.
- Upcoming revisions to the IEC 601601 series for electromedical devices.
- Technical challenges to sustainability and health equity.
Registration for AAMI members and member groups can be found here. Registration is also open for non-members, who are also strongly encouraged to attend. AAMI’s events team can be reached at [email protected] in the event of questions about registration, programming, or group registration rates.