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Automating Computer Systems Validation for Your QMS Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the software is used and what the user needs to do with it. By using this documentation, we …
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Ask the Expert: EU MDR as a Trigger for Innovation Much of what has been written about the EU MDR emphasizes the increased regulatory burden that it puts on medical device companies. Giotto Compliance looked at the bright side of the new regulations and viewed EU MDR requirements as a catalyst to drive innovation …
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White Houses Releases AI Bill of Rights Blueprint Against a backdrop of growing concern surrounding biased data and rights to privacy and informed consent, the White House has released the “Blueprint for an AI Bill of Rights” that lays out five principles and associated practices to protect the American public against potential harm. “Among …
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FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device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 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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