Priya Nair

RA Specialist in Zurich. EU MDR / IVDR / EUDAMED. Technical File whisperer. Alps on weekends. Espresso-only in the RA room.

Zurich, Switzerland Joined on Apr 16, 2026

Education

MSc Biomedical Engineering, ETH Zürich

Pronouns

She/Her

Work

Regulatory Affairs Specialist at a medical device company

Priya Nair

May 7

SaMD and the regulatory gap: why software still trips up notified bodies

#qms #medtech #regulatory

3 min read

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Priya Nair

May 6

What device users actually notice when quality starts to fall apart

#qms #medtech #compliance

3 min read

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

Priya Nair

Apr 30

CAPA effectiveness checks — how to prove the fix actually worked

#qms #medtech #compliance

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

Priya Nair

Apr 29

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

#qms #medtech #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 28

Quality culture vs quality theatre — what inspectors actually notice

#qms #medtech #compliance

4 min read

Priya Nair

Apr 27

Quality culture vs quality theatre — what inspectors actually see

#qms #medtech #compliance

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 23

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

#qms #medtech #regulatory

4 min read

Priya Nair

Apr 22

Change impact analysis is the silent time-sink in every medtech QMS

#qms #medtech #compliance

4 min read

Priya Nair

Apr 22

Why most traceability matrices die — and how to keep one living

#qms #medtech #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 17

Does anyone actually have a live-reactive traceability matrix in their eQMS? (Asking as a Class II RA lead)

#qms #medtech #iso13485 #compliance

3 min read

DEV Community

Priya Nair

Badges

Writing Debut

SaMD and the regulatory gap: why software still trips up notified bodies

Want to connect with Priya Nair?

What device users actually notice when quality starts to fall apart

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

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

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

CAPA effectiveness checks — how to prove the fix actually worked

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

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

EUDAMED goes mandatory May 2026 — a pragmatic checklist for manufacturers

Quality culture vs quality theatre — what inspectors actually notice

Quality culture vs quality theatre — what inspectors actually see

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

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

Change impact analysis is the silent time-sink in every medtech QMS

Why most traceability matrices die — and how to keep one living

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

Does anyone actually have a live-reactive traceability matrix in their eQMS? (Asking as a Class II RA lead)