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Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

Leave a Comment / compliance, cybersecurity, Digital Health, Focus Article, ISA/IEC 62443, Medical Device, medical device software, MedTech, Product Design & Development, Quality/Regulatory, RC - Device Design & Manufacturing, RTA, SOBM / By

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials     In recent years, more and more medical device manufacturers (MDMs) have come to rely on software bill of materials, or SBOMs. Some do this to help track licensing while others do so as part of a product vulnerability management process. In …

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FDA Releases Final Guidance on Premarket Submissions for Device Software Functions

Leave a Comment / Digital Health, Final Guidance, Medical Device, medical device software, MedTech, premarket submissions, Quality/Regulatory, RC - Medtech Regulatory Resource Center, software design / By

FDA Releases Final Guidance on Premarket Submissions for Device Software Functions     The FDA has released a final guidance on premarket submissions for device software functions. “Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. This …

FDA Releases Final Guidance on Premarket Submissions for Device Software Functions Read More »

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