A newsletter and reels by Faizan
The inner workings of medical device QA/RA, minus the boredom.
Short, honest lessons from inside a medical device quality system. For the newcomer lost in acronyms, and the veteran who has seen every finding twice.
- 5 yearsIn Class II medical device QA/RA
- 510(k)Led end to end, cleared a month early
- < 3 moQMS from nothing to ISO 13485 certified
- 90%+Of 23 CAPAs closed on time
01 — Why I do this
I trained to design machines. I ended up designing paperwork.
I’m a mechanical engineer by training. My first quality system wasn’t even mine. It was my boss’s, written for the FDA’s old QSR and an older ISO 13485.
He reviewed every procedure I rewrote. That’s where I learned to think in risk, not checklists.
Some of my procedures were unrealistic. We passed the audit anyway. Then our own internal audit caught them, and we fixed them.
Five years on, I lead a QA/RA team. Almost none of this was in a standard. So I write it down, one idea at a time, for the newcomer facing a first audit and the veteran who’ll nod along.
Head of QA/RA · ISO 13485 Lead Auditor · Lahore 
02 — The newsletter
Latest from Substack
One idea per post. Real lessons from audits, CAPAs and submissions, with one takeaway you can use tomorrow.
All posts on Substack-
Your QMS Is a Suit. Stop Buying It Off the Rack.
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I Inherited a QMS. Nobody Was Following It.
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I Built a QMS in Under Three Months. Here’s What It Cost.
Too tired to check Substack? Get the next post in your inbox.
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03 — On Instagram
Paper-folded reels
Each post, folded into a short origami video. Watch one between meetings.
Follow @the.paperwork.engineer
04 — Work together
Let’s talk.
Stuck on a submission, prepping for an audit, or living with a QMS that’s grown messy? Book a free 30-minute call. Bring the problem. Leave with an honest read on it and a clear next step.
Fair warning: ask me to “just build a QMS” and my first question will be, “At what cost?”
Prefer email? faizan@thepaperworkengineer.com
How I can help
- FDA 510(k) supportGet your submission cleared: strategy, drafting, and answers to FDA’s Additional Information requests
- ISO 13485 QMS buildsA quality system your team will actually follow, ready for certification
- Supplier auditsAn independent ISO 13485 audit of a supplier, ending in a clear go or no-go
- eQMS and CSA validationMove your records into an electronic system without losing a thing (21 CFR Part 11, CSA)
- Team trainingDesign controls, risk management, data integrity (ALCOA++) and the move from CSV to CSA