Software Traceability That Tells a Story: Connecting Requirements, Risk, Design, and Testing
Software Traceability That Tells a Story: Connecting Requirements, Risk, Design, and Testing Software traceability shows how a product idea becomes tested and approved software by connecting intended use and requirements with design, risks, test results, known issues, and the release decision.For software used in or as a medical device, US and European regulators expect evidence […]
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Risk-Based Software Planning: Where Requirements, Architecture, and Testing Work Together
Risk-Based Software Planning: Where Requirements, Architecture, and Testing Work Together Software developers build reliable functionality. For software as a medical device (SaMD), teams must also show that software remains acceptably safe when it fails, receives unexpected inputs, or is used under foreseeable conditions. Risk-based planning assesses potential failure impact to determine where stronger requirements, defensive […]
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Medical Device Cybersecurity: Bridging Enterprise Security and Product Security
Medical Device Cybersecurity: Bridging Enterprise Security and Product Security Most organizations still talk about cybersecurity as if it’s one thing. In reality, it operates across two distinct domains: enterprise security and product security. For years, these have evolved on parallel paths: different teams, different priorities, different tools. The assumption has been that alignment between them […]
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Medical Device Cybersecurity Requirements Under the EU MDR
Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers […]
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A Guide to FDA Clinical Decision Support (CDS) Software Approval
A Guide to FDA Clinical Decision Support (CDS) Software Approval Clinical decision support (CDS) software has become a critical element of healthcare delivery. It integrates with other devices and technologies to improve the quality and efficacy of healthcare by offering evidence-based information and suggestions, and alleviating some of the mental burden providers carry. In 2016, […]
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