Medical Innovation Exchange

automation

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices     On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. When finalized, “Computer Software Assurance for …

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Streamlining the Literature Review Process

Streamlining the Literature Review Process     Literature reviews play an integral role in the regulation of medical devices and technologies. We spoke with Evidence Partners’ CEO Peter O’Blenis to learn more about the challenges of literature reviews, their role in supporting patient safety and global regulatory approval, as well as new tools that help medtech …

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