See exactly where your QMS stands against ISO 13485 and FDA QMSR — every finding traced to the clause behind it.
The guides and crosswalks are free and live today; the automated scan of your own QMS is coming soon. FDA QMSR is now in enforcement — your internal audits and management reviews are inspectable records, so there’s still a window to find and close the gaps first.
Three situations we help with most often
You're 6–12 months from FDA submission and your QMS lives in Google Drive.
A free scan shows you where your QMS is solid and where the gaps are — while there's still time to close them.
If compliance is part of your job but not in your title, this is written for you too.
Plain-English guides for founders, engineers, PMs, etc. — grounded in the standards themselves.
You're mapping requirements across frameworks and need clause-level answers, not overviews.
167 requirements across six standards. Every clause mapped. No login, no paywall.
Compliance knowledge is not a product. It’s a public good.
Understanding regulations shouldn’t be hard, and neither should identifying the gaps in your QMS. So we publish the foundational references and guides free — and a free scan of your own QMS is on the way. We can go deeper if you need it.
Seven standards, in plain English
Practical requirements for each standard — what it demands, what evidence to produce, how it maps across frameworks.
Browse all guides →THE CROSSWALK167 requirements, one searchable map
Every clause mapped against the others across six frameworks — overlaps, additions, and the gaps in your QMS.
Open the crosswalk →Software speed with consultant depth.
Not a keyword scan. For every requirement that governs your device, the scanner reads your documents and asks the questions a careful reviewer would — is the intent addressed, where, and with enough specificity and evidence to hold up to an audit?
Your Risk Management Plan names risk control measures but does not document the option analysis the clause requires — why each control was chosen over alternatives.
What’s missing: a documented rationale comparing control options for each identified hazard.
The scan will be free — run it, act on the gaps, and scan again.
An automated gap analysis you review and re-run: each pass shows where your QMS stands, clause by clause, so you get closer to compliance every time. No sales call, no credit card to start.
Reviewed before publication. Audited on a cadence.
- Every guide carries a reviewed-by byline and a last-reviewed date.
- Scanner findings are grounded in our published requirements, each traced to its clause.
- Each requirement is cross-checked against the normative source standard.
Real people stand behind the methodology, the guides, and every review.
Kelsey Quality is built by people who have spent years working in highly regulated industries. We don’t compromise quality or accuracy for speed. Experienced life-science quality professionals advise the methodology and review the guides.
Read more about who we are and how we approach our workThree ways to start.
Read the guides, browse the crosswalks, or join the waitlist for early access to the scanner.