The Association for the Advancement of Medical Instrumentation
AAMI is a diverse community of more than 10,000 professionals united by one important mission — advancing safety in medical technology.
Upcoming Courses
Healthcare Technology Management
HTMLive! The insights that are driving the evolution of service agreements
We recognize the needs are changing for clinical engineers across the world to ensure the smooth operation of devices that are fundamental to patient care. Through ongoing focus groups, research, and recent conversations at the AAMI eXchange 2024, we understand the hurdles, challenges, and trends are impacting you the most. In this session, we’ll discuss the insights that are driving change at GE HealthCare within Patient Care Solutions as we support you and your teams in keeping your fleet of biomedical devices completely ready for care.
Expert Insights
Reprocessing for Medical Devices
Expert Insights
Transitioning to the FDA Quality Management System Regulation (QMSR)
The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.
Expert Insights
Mastering SaMD: Navigating Regulations & The Product Lifecycle
SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world. This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.
Expert Insights
Key Updates: AAMI ST58:2024 – Guidance for Chemical Sterilization
Join us as we go over all the major updates regarding processing (gaseous sterilization, liquid chemical sterilization, and high-level disinfectants) for reusable medical devices. The current version of AAMI ST58 was due for revision, as it was last updated in 2013. These updates will improve safety for personnel performing the processing and enhance patient outcome and experiences with the newly revised guidance.
Expert Insights
Understanding AAMI TIR99 – Guidance on Ultrasound Probe Processing
This training program is designed to equip healthcare professionals with the knowledge and skills necessary to ensure the safe and effective processing of dilators, transesophageal and ultrasound probes, in accordance with the guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 99.
Publications
AAMI NEWS
News from AAMI is a must-read resource
For those working in health technology, sterilization, and medical device manufacturing, design, and development.
As a central hub for standards, guidance, training, and resources spanning the entire life cycle of medical devices, AAMI can help you discover the unique and impactful connections between all facets of health technology.
KEEPING IT CLEAN
Using Standards and TIRs to Drive Consistent Sterile Processing Procedures
Standards and technical information reports (TIRs) from AAMI are critical resources for anyone involved in the processing and sterilization of medical devices. Learn more in the new BI&T cover story (log in to view).
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Our diverse community of more than 10,000 professionals is united by one important mission—the development, management, and use of safe and effective health technology.
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