October 2023 Recent medical device news highlights related to Class III implantable medical devices in the areas of cardiac rhythm management and diabetes treatment. Always ensure to follow up on the provided links for detailed information. I found MITs implantable device with pancreatic islet cells and an oxygen factory fascinating and scary. I would haveContinue reading “MedTech News”
Tag Archives: Medical Device Production
Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry
The Food and Drug Administration (FDA) has recently released a draft guidance that signals a significant shift in their approach to software used in the production and quality systems of medical devices. This new guidance, titled “Computer Software Assurance for Production and Quality System Software”, emphasizes a risk-based, lifecycle approach to software assurance, moving awayContinue reading “Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry”
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