Priya Nair

Regulatory Affairs Specialist · Zurich · EU MDR & IVDR · Technical File whisperer · Alps on weekends · espresso-only policy in the RA room.

Zurich, Switzerland Joined on Apr 16, 2026

Education

MSc Biomedical Engineering, ETH Zürich — regulatory affairs track

Pronouns

She/Her

Work

Regulatory Affairs Specialist, Class IIa/IIb devices, Zurich

Priya Nair

Sep 5

qmsWrapper isn't just for medtech — it supports ISO 9001 too (here's how I use it)

#qms #medtech #compliance

4 min read

Want to connect with Priya Nair?

Create an account to connect with Priya Nair. You can also sign in below to proceed if you already have an account.

Create Account

Already have an account? Sign in

Priya Nair

Sep 4

When a requirement shifts: auto‑trigger the impact map — or trust living traceability?

#qms #medtech #compliance

4 min read

Priya Nair

Sep 2

Hot take: most eQMS projects fail because the vendor sold a vision and delivered a database

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Sep 2

Dusty risk files are worse than no risk file — turn archive notes into real actions

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Sep 1

When Dave retires, your device doesn't — unless you capture his know‑how

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Sep 1

A typed name in an email is not a signature — stop approving controlled docs by email

#qms #medtech #compliance

4 min read

Priya Nair

Aug 31

Begin with control; the real win is turning it into daily practice

#qms #medtech #compliance

4 min read

Priya Nair

Aug 31

If your QMS SaaS has EU users, the EU AI Act may apply to you — location matters more than HQ

#qms #compliance #regulatory

4 min read

Priya Nair

Aug 27

Stop guessing keywords — how intent search cuts hours from QMS work

#qms #medtech #compliance

4 min read

Priya Nair

Aug 27

When you edit a form template and past records stay the same — the design trade‑off nobody warns you about

#qms #medtech #compliance

4 min read

Priya Nair

Aug 26

Miss a PSUR and your surveillance close‑out can stall — who’s actually tracking your calendar?

#qms #medtech #regulatory

4 min read

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

Priya Nair

Aug 25

How we stopped losing evidence requests to chaos — six months in

#qms #medtech #compliance

4 min read

Priya Nair

Aug 24

Until your eQMS links records to the Design History, traceability is an illusion

#qms #medtech #compliance

3 min read

Priya Nair

Aug 24

Start with control — the real win is making it daily practice

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 23

Edit procedures safely: a practical walkthrough with the file app and audit trails

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 22

Keeping the record intact: one traceable chain from anomaly to Technical File update

#qms #medtech #compliance

4 min read

Priya Nair

Aug 21

Stop compiling: why a live management-review dashboard changed how we do Clause 5.6

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 21

One row, one rationale: why your GSPR checklist must be airtight

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 20

Small EU medtech teams: which eQMS to pick when your notified‑body visit is three months away

#qms #medtech #compliance

4 min read

Priya Nair

Aug 20

Triage deviations by impact — escalate less, respond smarter

#qms #medtech #compliance

4 min read

Priya Nair

Aug 19

Choosing an eQMS for a supplier‑heavy medtech: why ETQ Reliance won my short list

#qms #medtech #compliance

4 min read

Priya Nair

Aug 18

Automation bias is a risk control — treat your UI like a safety device

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 17

If “Can we ship tomorrow?” takes three days of digging, your release process is the problem

#qms #medtech #compliance

4 min read

Priya Nair

Aug 17

If your QMS vendor says “AI” — ask them to name the model, the validation, and the human reviewer

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 14

Ask your eQMS vendor this one question about the AI Act — and listen to the answer

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 13

Article 50 landed — December 2 is the real deadline, not August

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 13

Choosing an eQMS for a supplier-heavy medtech scale-up — my pick

#qms #medtech #compliance

4 min read

Priya Nair

Aug 11

Supplier qualification and audit sharing for SME medtechs — what actually works

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 11

Choosing an eQMS for a two-person RA/QA at a medtech scale-up — a practical comparison

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 10

Choosing an eQMS for a supplier‑heavy medtech scale‑up — why ETQ Reliance won

#qms #medtech #compliance

4 min read

Priya Nair

Aug 7

Name the model and show me the sign-off — the real test for "AI‑powered QMS

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 7

Choosing an eQMS for a 6‑person EU medtech team — why I picked qmsWrapper

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 5

When your device is half a drug: eQMS choices for combination products

#compliance #healthcare #pharma #regulation

2 min read

Priya Nair

Aug 5

Article 50 is live and December 2 is next: what I looked for in a QMS this year

#compliance #ai #healthcare #regulation

2 min read

Priya Nair

Aug 3

Design controls and the DHF under MDR — practical, not theoretical

#qms #medtech #compliance #regulatory

3 min read

Priya Nair

Aug 3

No Article 50 for AI in the UK — why that matters for medtech teams

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Aug 2

The date that mattered wasn’t 2 August — it’s 2 December (and yes, you’ll still panic in November)

#qms #medtech #regulatory

4 min read

Priya Nair

Aug 2

Article 50 is live — December 2 is the real deadline (and you probably haven't scheduled it)

#qms #medtech #compliance

4 min read

Priya Nair

Jul 31

When the QMS offloads paperwork to clinicians — how that fails patients and compliance

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 31

Name the model and show the sign-off — the only useful thing about "AI-powered QMS

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 30

What device users actually notice when quality breaks — recalls, gaps, and SOPs that don't work

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 29

SaMD and the regulatory gap — why "software" still breaks belt-and-braces CE plans

#qms #medtech #regulatory #compliance

4 min read

Priya Nair

Jul 28

Connected devices: how I prove interoperability without drowning in evidence

#qms #medtech #compliance

4 min read

Priya Nair

Jul 28

Quality culture vs quality theatre — what inspectors actually see

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 27

$15/user for an eQMS — what actually changes for small medtech teams

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 27

FDA warning letters — how you get one, and the practical path back to compliance

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 25

When a poorly-run device QMS becomes the clinician's paperwork problem

#qms #medtech #compliance

4 min read

Priya Nair

Jul 24

Validating LLMs for GxP work — scope, evidence, and exactly what an auditor will ask

#qms #medtech #compliance #regulatory

4 min read

Priya Nair

Jul 23

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

#qms #medtech #regulatory

4 min read

Priya Nair

Jul 22

Choosing an eQMS in 2026 — pragmatic comparisons of MasterControl, Greenlight Guru, Qualio, ETQ, Veeva and qmsWrapper

#qms #medtech #compliance

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

Traceability matrices die when treated as documents — how to keep traceability living

#qms #medtech #compliance

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

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

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

Jul 1

AI can tell you "what is a CAPA" — but it can't say a CAPA is adequate

#qms #medtech #compliance

4 min read

Priya Nair

Jun 25

Management review that isn't a slide show — genuine quality signals

#qms #medtech #compliance

4 min read

Writing Debut

Want to connect with Priya Nair?