The Association for the Advancement of Medical Instrumentation

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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

Chemical Characterization of Medical Devices Workshop

This course provides an in-depth exploration of the chemical characterization process essential for assessing the biocompatibility of medical devices. Participants will gain insight into the latest regulatory expectations worldwide, with a focus on compliance with ISO 10993-17, ISO 10993-18, and industry best practices. 
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Expert Insights

Diagnostic AI Testing Best Practices for Regulatory Submissions

This course explores testing strategies and study design considerations for diagnostic AI models requiring premarket clearance by regulatory bodies like the USA FDA, EU MDR, and those adhering to ISO 13485 standards. Focusing on detection AI, the training covers bench and clinical testing, emphasizing their roles in bias mitigation, clinical effectiveness, and regulatory compliance.

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Expert Insights

Pre Post Market QMS Considerations for AI-ML-Enabled Medical Devices

This course offers a comprehensive overview of Quality Management System (QMS) considerations essential for the development and regulatory approval of diagnostic AI models classified as medical devices. It is specifically tailored for AI models requiring premarket clearance by the U.S. FDA, EU MDR, and other regulatory bodies that mandate adherence to ISO 13485 standards. 


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Expert Insights

TIR101 How Do IV Smart Pumps Really Work Only the Patient Knows

This webinar features an insightful discussion between a technical specialist, Bob, and a clinical specialist, Jeannine, focusing on the various factors that influence the accuracy of infusion pumps. The session will highlight the importance of the new TIR101 testing, which provides crucial data to help healthcare professionals make informed decisions at the bedside.

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Expert Insights

The Essential Elements of Human Factors Engineering in the Product Development Process

This course offers a concise overview of Human Factors (HF) in medical device design, focusing on its integration across all stages of product development, from concept to post-market surveillance (PMS).


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Quality Systems and Risk Management

Design of Experiments: A Faster, Better, Cheaper Methodology

People involved with designing and implementing production processes are often challenged with how to characterize their product or processes and, then, optimize results. This is especially true for medical device and pharmaceutical firms. What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality? This webinar is focused on a “Faster, Better, Cheaper” methodology.

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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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