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The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
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