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
We built Kelsey Quality to bring that same rigor to every company working to make safe, effective products — without requiring the time, cost, or luck of having a Frances Kelsey on staff.
Our tools scan your existing QMS documents against the standards that matter and show you where the gaps are, what they mean, and what to fix first. Fast, because the technology enables it. Thorough, because the standards demand it.
Regulatory compliance is the floor, not the ceiling. We help you get the floor solid so you can focus on what’s above it.
The problem
For smaller life science companies, the gap between “we need a QMS” and “we have a compliant QMS” 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.
What Kelsey Quality does
Kelsey Quality gives life science companies consultant-grade compliance assessment without consultant-grade cost or complexity. Our tools scan your existing QMS documents against the standards that matter — ISO 13485, the FDA’s QMSR, and related standards — and show you where the gaps are, what they mean, and what to fix first.
Kelsey Quality works with your existing quality system, whatever that looks like — Google Drive folders, SharePoint, Notion, or a dedicated QMS platform. No migration, no new system to learn. Connect your documents and get your report.
WHO BUILT THIS
Built by someone 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 was built in deep collaboration with regulatory professionals and validated against FDA enforcement data — real warning letters, real 483 observations, real audit findings. 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.
Free compliance review. Pay only for the detailed report.
No credit card. No sales call. No consultants required.
Start My Free Review →Read-only access. Your documents stay in your Drive.