About
Audit Readiness Without the Weeks of Digging
QMSAdvisor exists to give medical device quality teams a clear, honest picture of where their quality system stands, and a practical way to close the gaps, without moving their QMS into new software.
Mission
Why QMSAdvisor Exists
Getting ready for an audit usually means a few experienced people spending weeks reading documents they already know, looking for the contradictions and missing records an auditor will find. It's slow, it competes with running the quality system, and it often ends in a spreadsheet nobody owns.
We think that work should be split differently. Software is good at reading every document and cross-checking it. Experienced people are good at judgment: whether something is really a gap, how much it matters and whether a fix will stand up. QMSAdvisor gives each the part it does well.
With FDA now inspecting under the Quality Management System Regulation and Compliance Program 7382.850, and with internal audit, management review and supplier audit records open to inspection, a clear and current view of your quality system matters more than ever.
Approach
How We Work
Work With What Exists
Quality teams have already written their procedures and kept their records. We start from those, in whatever form they're in, rather than asking anyone to migrate a quality system to get an opinion on it.
People Make the Decisions
AI reads everything and drafts. A qualified advisor decides what is a gap, how serious it is and whether the evidence closes it. The platform enforces that order.
Show the Source
A finding that can't point to the document and passage behind it isn't ready to publish. Every finding carries its source.
Keep an Honest Record
Every decision is recorded in a history that can't be rewritten, because the best evidence that a gap was closed properly is the record of how it was closed.
Never Overpromise
FDA investigators, notified bodies and certification bodies decide outcomes. We help you prepare, and we say plainly what we can't promise.
Make Readiness Continuous
FDA usually gives about five days' notice of a routine inspection, and none for a for-cause one. Readiness that only exists the week before an audit isn't readiness.
Next Step
See What an Assessment Would Cover
Tell us about your devices and what's ahead, and an advisor will scope it with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
