CEO and co-founder, Dave DeRam shared feedback from a recent call, “To have a single source of truth for making design decisions and standing up to an FDA audit is a game changer within the industry.” ...
Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...
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 ...
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