Regulatory - DEV Community

Skip to content

DEV Community

👋 Sign in for the ability to sort posts by relevant, latest, or top.

Priya Nair

Aug 25

The cleanest way to keep your compliance‑AI out of the EU AI Act high‑risk class: AI proposes, a human approves and signs

#qms #compliance #regulatory

4 min read

James Whitfield

Aug 22

Picking an eQMS for a 200-person Class II device shop — a pragmatic comparison

#qms #medtech #compliance #regulatory

4 min read

James Whitfield

Jul 22

Letting AI touch CAPA: the validation question nobody actually answers

#qms #medtech #compliance #regulatory

4 min read

James Whitfield

Jul 21

Germany's 2026 medtech squeeze: EUDAMED + HTA and what my QMS actually had to change

#qms #medtech #regulatory

4 min read

Priya Nair

Jul 20

Traceability matrices break because you treat them like spreadsheets — here’s how to keep them living

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 19

When the QMS offloads paperwork onto clinicians — why that fails patients

#qms #medtech #compliance #regulatory

4 min read

James Whitfield

Jul 17

FDA warning letters: how they usually happen, and a realistic recovery path

#qms #medtech #compliance #regulatory

3 min read

Priya Nair

Jul 16

Change impact analysis across the Technical File — the hidden cost of a component swap

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 16

SaMD and the regulatory gap: what I actually ask for in a Technical File

#qms #medtech #regulatory #compliance

4 min read

James Whitfield

Jul 13

Where usability files actually break — and what I do about it

#qms #medtech #compliance #regulatory

3 min read

Priya Nair

Jul 13

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

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 1

Why small medtechs are quietly exiting the EU — and what I do differently when budgets tighten

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jun 25

AI for CAPA: fine for "what is it", risky for "is it adequate

#qms #medtech #compliance #regulatory

4 min read

James Whitfield

Jun 23

Every eQMS demo looks like electronic forms — which ones actually run workflows?

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jun 18

How the IVDR forced me to rethink CAPA — practical changes that actually stuck

#qms #medtech #compliance #regulatory

4 min read

👋 Sign in for the ability to sort posts by relevant, latest, or top.