In 1960, one FDA reviewer refused to approve thalidomide without sufficient evidence.
We named the company after her, and we work the same way: evidence first, because that’s what puts more safe, effective, and compliant products in the world.
Frances Oldham Kelsey (1914–2015) was a Canadian-American pharmacologist and FDA reviewer. Her insistence on evidence prevented thousands of birth defects and led directly to the Kefauver-Harris Amendment, which strengthened US drug safety regulation. President Kennedy awarded her the President’s Award for Distinguished Federal Civilian Service in 1962 — only the second woman to receive it.
Her story is also a reminder of the role women have played, and continue to play, in science, regulation, and patient safety.
What we built — and why
Kelsey Quality is two things at once. An open reference — plain-English guides and a clause-by-clause crosswalk across the standards that govern a medical device QMS, free to read and live today. And a scanner that checks your existing documents against those same standards and shows you where the gaps are, what they mean, and what to fix first.
It works with the quality system you already have — Google Drive today; SharePoint, Notion, or a QMS platform next. No migration, nothing new to learn. And it supports the people responsible for that system rather than replacing them: an automated scan you review and re-run, handing your team a cited gap analysis to act on.
Between “do we need a QMS?” and “we’re audit-ready” sits an expensive, slow gap. Consultants charge $2–15K for a gap assessment. Enterprise QMS platforms run $12–25K a year and up. Template bundles hand you documents without telling you whether they cover what the standard requires.
So companies invest in compliance and still can’t tell whether they’ve done enough. Regulatory compliance is the floor, not the goal — we help you get it solid so your team can focus on making the product safe and effective.
Built from inside the QMS industry, not outside it looking in.
Kelsey Quality was founded by Todd Wilkens — 25+ years leading product, design, and technology, the last decade in highly-regulated global industries:
- Chief Product & Technology Officer, Qualio— 2023–24 · life-science QMS; built AI-driven multi-framework compliance gap analysis · FDA QMSR · ISO 13485 · 21 CFR Part 11
- Chief Product Officer, Remote— 2022–23 · global employment, payroll & benefits · GDPR · global labor & payroll law
- Chief Product Officer, Auctane(ShipStation, ShipEngine) — 2019–21 · logistics, 1B+ annual shipments · customs, trade & carrier compliance
- SVP & GM, WooCommerce / Automattic— 2016–19 · ran WooCommerce post-acquisition · P&L owner, $15B+ GMV · PCI DSS · PSD2/SCA · global tax
- Earlier:product & design leadership at Atlassian, IBM, and the Mayo Clinic
Focus areas: FDA QMSR (21 CFR 820) · ISO 13485:2016 · IEC 62304 · IEC 62366 · ISO 14971 · 21 CFR Part 11 · medical-device cybersecurity
Profiles: LinkedIn · toddwilkens.com
Every requirement traces to its source clause in the published standard, cross-checked against FDA enforcement data — warning letters, 483 observations, audit findings. Experienced quality professionals advise the methodology and review the work. This is not a keyword matcher.
We publish how our content is sourced, reviewed, and corrected, including how to report an error. See our editorial policy.
A free structural scan is coming.
No credit card. No sales call. No consultants required.