MedTech news roundup August 2023
Our August 2023 MedTech news roundup covers upcoming legislative changes for Post-Market Surveillance in the UK, updates from the EU…
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Off-The-Shelf software in medical devices | FDA guidance
The FDA has issued updated guidance on Off-The-Shelf software in medical devices. The document, which supersedes a previous version issued…
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How to achieve effective software segregation
The idea of breaking down a complex problem into smaller, more manageable challenges is a well-established concept. In software design,…
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Preparing your Premarket Submission for Device Software Functions
The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
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