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

Oct 4

A partner-side QMS rollout playbook — five phases I run the same way at every client

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Oct 3

The 0.87 problem: when semantic linking makes inconsistent records look connected

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Oct 2

The CER grew. The clinical evidence didn't. We let the report outpace the data.

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Oct 1

Why our CAPA effectiveness check keeps coming back as an audit finding

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 30

6 eQMS picks for a supplier-heavy medtech CMO — why ETQ Reliance earns the plant floor

#qms #medtech #compliance #testing

5 min read

Rajiv Iyer

Sep 29

7 eQMS picks for a supplier-heavy CMO — what survives daily QSIT discipline

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 28

DEKRA's first ISO 9001:2026 gap is "assumed readiness" — and most transition plans are built on it

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 27

Half a day chasing one AI suggestion — and the rationale wasn't there

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 24

Six eQMS picks for a supplier-heavy CMO — and the one I'd actually buy

#qms #medtech #compliance #testing

3 min read

Rajiv Iyer

Sep 23

Stop running two systems: how project management drives a real QMS workflow

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 22

CMA for QMSR is won at the input — clean supplier data beats clever script tricks

#qms #medtech #compliance #testing

4 min read

Rajiv Iyer

Sep 21

I stopped filling out the form — what auto-triggered QMS events taught me at a CMO

#qms #medtech #compliance #testing

4 min read

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

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Skills/Languages

A partner-side QMS rollout playbook — five phases I run the same way at every client

The 0.87 problem: when semantic linking makes inconsistent records look connected

The CER grew. The clinical evidence didn't. We let the report outpace the data.

Why our CAPA effectiveness check keeps coming back as an audit finding

6 eQMS picks for a supplier-heavy medtech CMO — why ETQ Reliance earns the plant floor

7 eQMS picks for a supplier-heavy CMO — what survives daily QSIT discipline

DEKRA's first ISO 9001:2026 gap is "assumed readiness" — and most transition plans are built on it

Half a day chasing one AI suggestion — and the rationale wasn't there

Six eQMS picks for a supplier-heavy CMO — and the one I'd actually buy

Stop running two systems: how project management drives a real QMS workflow

CMA for QMSR is won at the input — clean supplier data beats clever script tricks

I stopped filling out the form — what auto-triggered QMS events taught me at a CMO

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