ABOUT
In 1960, one FDA reviewer refused to approve thalidomide without sufficient evidence. She saved thousands of lives.
We named our company after her.
Frances Oldham Kelsey (1914–2015) was a Canadian-American pharmacologist and FDA reviewer. Her insistence on sufficient evidence prevented thousands of birth defects and led directly to the Kefauver-Harris Amendment, which strengthened drug safety regulations in the United States.
She was awarded the President’s Award for Distinguished Federal Civilian Service by President Kennedy in 1962 — only the second woman to receive the honor.
Frances Kelsey represents what we believe quality work should be: intelligent, determined, sincere, and uncompromising on the things that matter. Her story also reminds us of the pioneering 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. The first is 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.
The second is our scanner, which gives life science companies consultant-grade compliance assessment without consultant-grade cost or complexity. It scans your existing QMS documents against the standards that apply to you — ISO 13485, the FDA’s QMSR, and related standards — and shows you where the gaps are, what they mean, and what to fix first.
The scanner supports the people responsible for your quality system — your team and the experts they bring in — rather than replacing them. It does the systematic first pass and hands them a cited gap analysis to review and act on.
Kelsey Quality works with your existing quality system, whatever that looks like — Google Drive folders today, with SharePoint, Notion, or a dedicated QMS platform in the near future. No migration, no new system to learn. Connect your documents and get your report.
We saw the same challenges over and over. Especially for smaller life science companies, the gap between “do we need a QMS?” and “we are audit-ready” is expensive, confusing, and slow to close. External consultants charge $10K–$50K for a gap assessment. Enterprise QMS platforms cost $25K or more per year. And template bundles give you documents without telling you whether they actually cover what the standard requires.
The result: companies invest in compliance but can’t tell whether they’ve done enough. They build QMS libraries in Google Drive and hope for the best.
Regulatory compliance is the bare minimum. Safety and effectiveness are the real goal. We help you get compliant so your team can focus on what really matters.
WHO BUILT THIS
Built by and for people with deep experience inside the QMS industry — not outside it looking in.
Kelsey Quality was founded by Todd Wilkens. He’s spent 25+ years as a product, design, and technology leader — the last decade in senior roles building products 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
Education: BA Computer Science, University of Texas · graduate study, UNC Chapel Hill
Also: 3 U.S. patents · co-author, Subject to Change (O’Reilly) · 20+ years working with AI
Profiles: LinkedIn · toddwilkens.com
The compliance logic behind Kelsey Quality is grounded in the published standards themselves — every requirement traced to its source clause — and cross-checked against FDA enforcement data: real warning letters, real 483 observations, real audit findings. Experienced quality professionals advise the methodology and review the work. This isn’t a keyword matcher or a checklist generator; the system understands how the standards relate to each other and what auditors actually look for.
We built Kelsey Quality because we saw the gap firsthand — and because we believe the companies making medical devices, pharmaceuticals, and biotech products deserve better options than the choice between a $500 template pack or a $50K QMS platform they may not need yet.
We also document how our published content is sourced, reviewed, and corrected. Every requirement traces to an authoritative standard, we re-verify on a published cadence, and we tell you how to report an error. See our editorial policy.
A free compliance scan is coming.
No credit card. No sales call. No consultants required.
We'll notify you when the scanner launches. No spam.