The Association for the Advancement of Medical Instrumentation recently updated one of its guidance documents on ethylene oxide (EO) sterilization.
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AAMI
Guide to AAMI eXchange
AAMI eXchange is back! The 2024 edition of the conference will be held in Phoenix, Arizona from June 14-17, 2024.
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New QMSR Rule is Final, FDA Aligns U.S. Med Device Regulation with International Standard
QMSR incorporates the internationally recognized quality management systems standard by reference, and FDA has proposed additional rules to ensure that the document aligns with existing FDA requirements.
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Rise of AI Demonstrates the Importance of Standards Development
According to Dr. David Classen, professor of medicine at the University of Utah and chief medical information officer at Pascal Metrics, patient safety is the one of the more pressing issues in the American medical system. But with the help of new tools like artificial intelligence (AI) and the adoption of new industry standards, there may be light at the end of the proverbial tunnel.
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FDA Eyes Biological Evaluation Standards
The U.S. Food and Drug Administration (FDA) has been actively engaged in the development of standards that medical device manufacturers use as their reference for conformance to FDA guidance. This is especially true for standards that address requirement for biomaterials used in medical devices that come in contact with the body.
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Overkilling Uncertainty, New TIR Seeks Clarity for Interpreting Bioburden Data
When companies are testing a medical device’s bioburden – a measure of how much and what types of viable organisms are in or on it after manufacturing – they might question how exact their results should be or what to do if the numbers seem off.
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