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 ...

India has brought AI-based diagnostic software under medical device regulations, mandating government licences and clinical ...

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