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AAMI News BI&T Press Room Engage Engage AAMI Connect AAMI StMP Store Store Catalog AAMI eSubscription AAMI Products Account My Account Logout Login Focus Areas HTM HTM Overview HTM Resources Resources Overview HTM in a Box HTM Academic Programs HTM Webinars HTM Associations Cybersecurity Resources for HTM BMET Apprenticeship HTM Week #IamHTM Search for Jobs Product Spotlight Sterilization Sterilization Overview ANSI/AAMI ST79 ANSI/AAMI ST91 Sterilization Training Medical Devices and Technology Medical Devices and Technology Overview Top Resources Participate in Standards Training Cybersecurity Cybersecurity Overview Top Resources Participate in Standards Training Search for Jobs Standards Standards Featured Standards ANSI/AAMI ST79 ANSI/AAMI ST91 2021 ANSI/AAMI ST98 ANSI/AAMI ST108 ANSI/AAMI PB70:2022 Committee Resources How are Standards Developed Participate in Standards Development View Full Committee List Search For a Committee Standards Monitor Online AAMI Standards Insider COVID-19 Resources Events All Events AAMI neXus 2024 AAMI eXchange24 AAMI Center for Excellence Hotels Near AAMI Training Overview Courses by Topic Quality Systems Human Factors Sterilization Software/Cybersecurity Healthcare Technology Management (HTM) Regulatory Expert Insights from AAMI Training Private Training Access My Learning Certification ACI Home Maintain Your Certification ACI FAQs and Resources Certification Directory Membership Membership Individual Membership Institutional Membership Corporate Membership Mentorship Program Career Center AAMI Town Halls 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. Register for AAMI eXchange June 14-17, 2024 | Phoenix, AZ Learn More Advertisement Featured Standards Upcoming Courses 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. Details 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. Details 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. Details 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. Details 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. Details Expert Insights Machine Learning for Medical Devices With the rise in Big Data and increased horsepower of computing platforms, there is a surge in the development of Machine Learning-based Medical Devices (MLMD.) As with any new technology, there are many benefits, risks, and challenges in the safe and effective development and adoption of MLMD. Details 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. READ MORE 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). READ MORE 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. LEARN MORE FOLLOW US! 901 N. 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