Page 4 – Kalpesh Hegde

Still trusting your SaMD Developer: How MD and IVD Regulation Inherited a Cybersecurity Knowledge Gap It Cannot See

Let me ask you something uncomfortable….

When was the last time a regulatory submission was rejected because the threat model

Kalpesh Hegde May 20, 2026

Your Wearable Knows Your Hormone Levels. So What? Data without a decision is just noise

There is a particular kind of frustration that comes from being handed a number with no context. Your heart rate

Kalpesh Hegde May 14, 2026

The “Second Puberty” Glitch: Is Your Glucose Crashing Your Menopause?

For decades, the metabolic changes of menopause were treated as a black box. Women were told to “eat less and

Kalpesh Hegde April 28, 2026

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