The DHF under MDR: stop treating it as paperwork, make it the device story

<p>I’ve spent the last three years defending algorithm updates to notified bodies and answering the same auditor question: “Show me how you control changes to this model.” For

<p>I’ve spent the last five years arguing with testers, architects, and notified-body assessors about why a device “doesn’t work with the hospital network”. To be fair, network

<p>If you work on software or tooling for medical device manufacturers, you've probably run into IVDR (Regulation (EU) 2017/746) somewhere in a requirements doc. It's the

<p>I work in a 200-person Class II medical device company with two QA/RA folks, three embedded-hardware teams, a small supplier-quality group, and engineers who want automation —