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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
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Transitioning to the FDA Quality Management System Regulation (QMSR) (Aug 2024)
Aug 27 to Aug 29, 2024
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Understanding AAMI TIR99:2024 - Ultrasound Probe Processing Guidance (Sep 2024)
Sep 9 to Sep 9, 2024
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Mastering SaMD: Navigating Regulations & The Product Lifecycle (Sep 2024)
Sep 17 to Sep 19, 2024
Featured Courses
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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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Reprocessing for Medical Devices
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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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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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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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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.
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Machine Learning for Medical Devices
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Key Updates AAMI TIR162023 - Microbial Factors for EO Sterilization
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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.
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Understanding ANSI - AAMI SW962023 – Security Risk Management Guidance
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Radiology Equipment Servicing 101 for HTM Professionals
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FMEA Without Tears
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Lean Six Sigma Core Concepts for HTM Professionals (March 2024)
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Key Updates: AAMI TIR45:2023 - Guidance on Agile Practices
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Validation of Analytical Procedures - Made Easy
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Acceptance Sampling Plans - Cutting Through the Jungle
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Risk-Based Computer Software Assurance Approach for PPQS
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Medical Device Cybersecurity 101 for HTM Professionals
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Test Method Validation: Tools and Methods to Meet FDA Requirements
Test Method Validation (TMV) is not only an FDA regulatory requirement, but also key to quality and financial success for a firm. After applying TMV, a firm saved $40 million. Another firm lost a $1 billion contract because they consistently shipped defective product – and the solution was easy using TMV. It all boils down to: How do you know that you have quality if you cannot measure?
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