Rajiv Iyer

QA tech lead @ a bangalore contract manufacturer · ISO 13485 + automation tooling · cricket, filter coffee · own views

Bangalore, India Joined on Aug 5, 2026

Education

Engineering, IIT Madras (2005–09)

Work

QA tech lead at a medical device contract manufacturer, Bangalore

Rajiv Iyer

Sep 20

A document without a trustworthy birth certificate is just a file — fixing the lifecycle before audit finds it

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 19

Every CAPA needs a project ID first, or you will retrace at audit

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 18

Your traceability matrix is stale — here is what a notified body actually wants to see

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 17

The change takes 30 minutes, the impact analysis takes 3 days — that's the part AI actually helps

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 16

A CMO walks through qmsWrapper's traceability matrix setup — and flags where it stops fitting

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 15

A TIL on qmsWrapper's version logic — and the supplier-side half it doesn't cover

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 14

Right-sized is a feature, not a compromise — qmsWrapper's scope, honestly

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 13

Six eQMS picks for a supplier-heavy CMO — and why the device-maker favourite falls short on plant work

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 12

The 14 documents nobody maps until the auditor asks

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 11

UK-only QMS shops with EU customers: does the AI Act's chatbot disclosure duty reach you?

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 10

The escalation triage problem — how to stop drowning in medtech quality noise

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 8

Early signals are the defensible part of a CAPA story — capture why, not just what

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 7

Half a day chasing AI-model traceability — how a CAPA from data provenance broke the loop and how we fixed it

#qms #medtech #compliance #regulatory

4 min read

Rajiv Iyer

Sep 6

Two quick questions every QMS person should ask about AI — fix these first

#qms #compliance #regulatory

4 min read

Rajiv Iyer

Sep 5

MDSAP: the one audit that can stop you paying for the same inspection five times

#qms #medtech #compliance

4 min read

Rajiv Iyer

Sep 4

The CoA parser that had to get worse before it got useful

#python #parsing #manufacturing #datascience

4 min read

Rajiv Iyer

Sep 3

7 eQMS picks for a supplier‑heavy CMO — why ETQ Reliance wins for plant work

#qms #medtech #compliance

4 min read

DEV Community

Rajiv Iyer

Badges

Writing Debut

Skills/Languages

A document without a trustworthy birth certificate is just a file — fixing the lifecycle before audit finds it

Every CAPA needs a project ID first, or you will retrace at audit

Your traceability matrix is stale — here is what a notified body actually wants to see

The change takes 30 minutes, the impact analysis takes 3 days — that's the part AI actually helps

A CMO walks through qmsWrapper's traceability matrix setup — and flags where it stops fitting

A TIL on qmsWrapper's version logic — and the supplier-side half it doesn't cover

Right-sized is a feature, not a compromise — qmsWrapper's scope, honestly

Six eQMS picks for a supplier-heavy CMO — and why the device-maker favourite falls short on plant work

The 14 documents nobody maps until the auditor asks

UK-only QMS shops with EU customers: does the AI Act's chatbot disclosure duty reach you?

The escalation triage problem — how to stop drowning in medtech quality noise

Early signals are the defensible part of a CAPA story — capture why, not just what

Half a day chasing AI-model traceability — how a CAPA from data provenance broke the loop and how we fixed it

Two quick questions every QMS person should ask about AI — fix these first

MDSAP: the one audit that can stop you paying for the same inspection five times

The CoA parser that had to get worse before it got useful

7 eQMS picks for a supplier‑heavy CMO — why ETQ Reliance wins for plant work