Skip to content

DEV Community

# regulatory

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

Priya Nair

May 4

The hidden regulatory cost of a “simple” component swap in your Technical File

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

May 1

CE marking under MDR — what's genuinely new, and what teams still get wrong

#medtech #regulatory #compliance

4 min read

Priya Nair

Apr 30

MDR’s hidden toll: why small medtechs are exiting the EU market

#qms #medtech #regulatory

4 min read

James Whitfield

Apr 30

How we built PMS reports that actually survive a notified-body audit

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Apr 29

FDA warning letters: how you usually get there, and the realistic recovery path

#qms #medtech #regulatory

4 min read

James Whitfield

Apr 28

What device users actually notice first when quality starts to fall apart

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Apr 28

EUDAMED goes mandatory May 2026 — a pragmatic checklist for manufacturers

#qms #medtech #regulatory #compliance

4 min read

Priya Nair

Apr 23

Predetermined change-control plans for AI/ML devices — practical steps that actually survive an audit

#qms #medtech #regulatory

4 min read

James Whitfield

Apr 23

Quality culture vs quality theater — what inspectors actually notice

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Apr 23

Germany’s 2026 medtech squeeze: EUDAMED plus HTA — what I’m telling my product teams

#medtech #regulatory #compliance

4 min read

Priya Nair

Apr 21

Why PMCF under MDR feels harder than it reads (and what I actually do about it)

#medtech #regulatory #compliance #qms

4 min read

Priya Nair

Apr 29

CAPA effectiveness checks: why "closed" isn't the same as "effective

#qms #medtech #compliance #regulatory

4 min read

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