About

I Built Medtronic's Audit Readiness Program. Now I'm Helping You Hit the QMSR Deadline.

Fixed-price QMSR compliance — because I'm confident enough to absorb the risk.

The Problem

The February 2, 2026 QMSR deadline is real. Thousands of medical device companies need to transition from 21 CFR 820 to an ISO 13485-aligned quality system — and most haven't started.

Traditional consulting firms will quote you hourly rates, staff your project with junior analysts, and bill you for every scope change. Six months later, you're over budget and still not audit-ready.

I built QMS.Coach to fix that.

My Approach

I use AI to compress what traditional consultants stretch into months-long engagements. Gap analysis that used to take weeks? Done in days. Documentation templates customized to your operations? Generated and refined in hours, not billable increments.

I studied AI applications in pharma and biotech at MIT Sloan — not to chase a buzzword, but because I saw what it could do to compress timelines. That's not a promise. It's math.

But AI alone doesn't pass FDA inspections. I pair that efficiency with hands-on experience from Medtronic, Edwards Lifesciences, and Endologix — companies where audit readiness isn't theoretical.

The result: fixed-price engagements delivered fast, with the regulatory depth to actually hold up under scrutiny.

About Neelank ("Neel") Tiwari, MS, PMP, CMDA, Founder

I came into medical devices through bioengineering — I understand how these products work, not just how to document them. That technical foundation, combined with hands-on audit experience at Medtronic, Edwards, and Endologix, means I catch quality gaps that pure compliance consultants miss.

I've spent my career in the rooms where audits happen — and in the war rooms where companies scramble to prepare for them.

At Medtronic, I led the Enterprise Audit Readiness program for FDA For Cause Inspections and Notified Body Audits. The outcome: 40% reduction in audit findings across multiple product portfolios.

At Edwards Lifesciences, I owned supplier changes from intake to approval — risk assessments, qualification planning, and audit-ready PLM documentation.

At Endologix, I served as FDA audit SME and navigated 70+ supplier change evaluations for EU MDR compliance.

I'm an ISO 13485 Lead Auditor. I know what auditors look for because I'm trained to be one.

Credentials:

BS, Bioengineering & Biomedical Engineering — UC Riverside
MS, Technology and Innovation Management
MIT Sloan — Artificial Intelligence in Healthcare, Pharma and Biotech
PMP (Project Management Professional)
CMDA (Certified Medical Device Auditor)
CQA (Certified Quality Auditor)
CSQP (Certified Supplier Quality Professional)
ISO 13485 Lead Auditor

I founded QMS.Coach because I watched too many companies burn cash on consultants who stretched timelines and padded hours. The QMSR deadline creates urgency. My model creates accountability.

Why Fixed-Price?

Hourly billing incentivizes inefficiency. The longer your project takes, the more the consultant earns.

Fixed-price flips that. I scope the work, quote the price, and deliver. If I underestimated, that's my problem — not yours.

I can offer this because:

I've done this before. Enterprise audit readiness at Medtronic wasn't a one-off — it was a repeatable system.
AI compresses timelines. What takes traditional consultants 3 months, I deliver in weeks.
I'm betting on myself. Fixed-price only works if you're confident. I am.

Advisory Network

For engagements requiring specialized depth — former FDA reviewers, EU MDR Authorized Representatives, specific therapeutic area expertise — I maintain relationships with vetted advisors who can be brought in as needed.

You always work directly with me. Advisors supplement; they don't substitute.

The Bottom Line

The QMSR deadline is February 2, 2026. You need a compliant quality system by then — not a proposal, not a roadmap, not a "phase 1 assessment."

I built the audit readiness program at one of the world's largest medical device companies. Now I'm offering that same methodology to companies who need to move fast and can't afford to guess.

[Book a Free Strategy Call] — 30 minutes, no pitch. Let's see if you actually need help or if you're further along than you think.