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.


Thank you to our 2024 AAMI eXchange Attendees!

We look forward to seeing you again next year in New Orleans, June 20-23, 2025

 

 

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Featured Standards

 

Upcoming Courses

Expert Insights

Risk Management for Machine Learned Enabled Devices

Machine learning systems can fail in unusual and unexpected ways, when compared to traditional software products. This course will highlight those differences and will also provide a snapshot of the current standards and regulatory landscape associated with the risk of machine learning enabled medical devices.

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Regulatory

Practical Post Market Surveillance for Medical Devices

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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.

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Expert Insights

Reprocessing for Medical Devices

This course provides a comprehensive overview of the cleaning, disinfection, and sterilization validation of medical devices requiring those processes before clinical use to ensure patient safety.
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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.

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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.  


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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.

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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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BECOME A MEMBER

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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