Expert Insights
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Upcoming Events
Expert Insights
Understanding ANSI/AAMI SW96:2023 - Security Risk Management Guidance (Jul 2024)
Jul 30 to Aug 1, 2024
Expert Insights
Transitioning to the FDA Quality Management System Regulation (QMSR) (Aug 2024)
Aug 27 to Aug 29, 2024
Expert Insights
Understanding AAMI TIR99:2024 - Ultrasound Probe Processing Guidance (Sep 2024)
Sep 9 to Sep 9, 2024
Expert Insights
Mastering SaMD: Navigating Regulations & The Product Lifecycle (Sep 2024)
Sep 17 to Sep 19, 2024
Featured Courses
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Expert Insights
Practical Post Market Surveillance for Medical Devices
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
Reprocessing for Medical Devices
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
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
Understanding ANSI - AAMI SW962023 – Security Risk Management Guidance
![](https://aami.org/images/default-source/training-topic-covers/st108cover.png?sfvrsn=bf63c32b_3)
Expert Insights
Navigating ANSI/AAMIST108:2023 Guidelines for Water Quality
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
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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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.
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Expert Insights
Machine Learning for Medical Devices
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Expert Insights
Risk-Based Computer Software Assurance Approach for PPQS
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
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.
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Regulatory
Key Updates - AAMI TIR48 - 2024 – QMS Recommendations for Combo Products
AAMI TIR48:2024, “Quality Management Systems (QMS) Recommendations on Application of the U.S.FDA's CGMP Final Rule on Combination Products,” has been updated to reflect the evolution in regulations and guidance for applying the US FDA cGMP Final Rule on Combination Products.
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
Key Updates AAMI TIR162023 - Microbial Factors for EO Sterilization
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
Navigating AAMI TIR106:2024 – Understanding Product Bioburden Data
This educational training session aims to familiarize participants with the newly established AAMI Technical Information Report (TIR), AAMI TIR106:2023, Microbiological methods — Understanding and Use of Product Bioburden Data.
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
Radiology Equipment Servicing 101 for HTM Professionals
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
FMEA Without Tears
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Expert Insights
Acceptance Sampling Plans - Cutting Through the Jungle
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Expert Insights
Key Updates: AAMI TIR45:2023 - Guidance on Agile Practices
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
Mastering HTM Accreditation Compliance: Stress Less, Achieve More
![](https://aami.org/images/default-source/uploadedimages/art/training/expert-insights.png?sfvrsn=6be689c5_1)
Expert Insights
Validation of Analytical Procedures - Made Easy
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Expert Insights