QMSR Readiness Assessment

Are you ready for the QMSR? FDA’s new Quality Management System Regulation (QMSR) lands in February 2026 and it will raise the bar by aligning more closely with ISO 13485. If your system has grown up around 21 CFR 820, the big question is simple: have you already covered the key differences — or are there gaps hiding in plain sight?

Our QMSR Readiness Assessment is a high-level, sample-based gap analysis designed to quickly identify whether the most important QMSR-vs-ISO 13485 topics are addressed in your QMS and where further work is likely needed. This assessment gives you a clear, prioritised view of what to tackle now, so you’re not forced into rushed, expensive rework later.

What’s included

1) 30-minute onboarding

We start with a practical 30-minute onboarding session where we explain:

what we will review (high level)
which ISO 13485 aspects we will check (in plain language, not “perfect process-name”-dependent)
what information we need from you to make the review meaningful

2) Offline document review (high-level, sample-based)

We review the documents you provide, focusing on whether key QMSR-relevant differences from a classic QSR setup appear to be covered, and where gaps are likely.

3) 60-minute closing meeting + written summary of findings

We walk you through the findings, answer questions, and you receive a clear written summary of what we found and what to prioritise next.

What you get out of it

A clear, management-friendly view of QMSR readiness (without weeks of disruption)
Practical feedback on whether the reviewed areas suggest further revision is needed
Prioritised gap themes plus general options for addressing them.

Scope & approach

This assessment is intentionally high-level and sample-based. That’s the point: it gives you a rapid, low-disruption signal on whether the key QMSR-vs-ISO 13485 differences are already addressed, and where to concentrate your effort next.

How it works

We review a targeted selection of documents and evidence (not everything).
We flag likely gaps and risk areas based on what we see in the sample.
You get a clear summary of findings plus practical, general ways to address them.

What you can expect

A quick, credible baseline before you invest heavily in remediation
Sharper prioritisation (so you’re not fixing things that don’t matter)
A clean handover into internal updates or a deeper follow-up review, if needed.

What it’s not trying to be

Because it’s designed to be fast and targeted, it’s not:

an exhaustive, clause-by-clause certification audit
a full QMS rebuild programme
a bespoke implementation plan tailored down to your exact templates and workflows.

If you decide you want hands-on remediation afterwards, great—we can map the right next step. But this package is built to do the most valuable thing first: identify and clarify the gaps that matter.