Page 2 – Kalpesh Hegde

A Billion-Dollar Company Just Posted the Regulatory Job Post That Changes Everything for Medical Devices

A company that treats regulation as paperwork feels that movement as risk. A company that has built real regulatory firepower

Kalpesh Hegde August 3, 2026

QMS/QA/RA is not cost center – Yes we are! Its not an insult its a valuation!

Every few weeks someone in my field publishes a post arguing that Quality and Regulatory is not a cost center,

Kalpesh Hegde July 15, 2026

IEC 62304 assumed your Medical Device software would sit still. AI just proved it wrong

Scroll through any regulatory forum right now and you’ll find the same fight: is this feature Class I or Class

Kalpesh Hegde July 11, 2026

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