Regulatory - DEV Community

Skip to content

DEV Community

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

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

Priya Nair

Jun 16

Annex I §17.2: the cybersecurity checklist I actually use in Technical Files

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jun 4

AI can explain CAPA — but it cannot certify adequacy (here’s how I use it)

#qms #medtech #compliance #regulatory

4 min read

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