Compliance insight that doesn't require an expert on staff.
The problem
Life science companies know they need a quality management system. Regulatory submissions require it. Audits depend on it. Patient safety demands it.
But for smaller companies — startups, early-stage manufacturers, growing teams — the path to compliance is expensive and opaque. 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.
Fast, because the technology enables it. Thorough, because the standards demand it.
About the name
Kelsey Quality is named for Frances Oldham Kelsey (1914–2015), a Canadian-American pharmacologist and FDA reviewer. In 1960, she refused to approve thalidomide for the US market despite intense pressure from the manufacturer. 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, 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.
We built Kelsey Quality to bring that same rigor to every company working to make safe, effective products.
Who built this
Kelsey Quality was built by Todd Wilkens, based on deep collaboration with regulatory professionals. Todd spent over four years as Chief Product and Technology Officer at Qualio, a quality management platform for life science companies. Before that, he led product teams focused on research and customer insights at companies including Citrix, Adobe, and Robert Half International.
The idea for Kelsey Quality came from watching hundreds of life science companies struggle with the same problem: they needed compliance insight but couldn't justify the cost or complexity of the tools that existed. The result is a product built on deep domain knowledge, designed to be genuinely useful from the first scan, and priced so that any company working on compliance can afford it.
Free compliance review. Pay only for the detailed report.
No credit card. No sales call. Results in minutes.
Start My Free Review →Read-only access. Your documents stay in your Drive.