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FDA’s Draft Guidance – A New...

By John Lafferty Article updated: March 2025 Read time: 3 minutes The draft guidance entitled Computer Software Assurance for Production and Quality System Sof...

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How to Make Software Validation Easier f...

By John Lafferty Software Validation just got a whole lot easier. The effort required comply with the software validation requirements of ISO 13485:2016 and 2...

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