The 21 CFR Part 820
/ QMSR Training
Specialists
We built the 21 CFR Part 820 / QMSR Training Management platform that FDA-regulated device companies rely on — because we understood the regulation before we wrote the first line of code.
Generic LMS platforms weren't built with 21 CFR Part 820 / QMSR Training Management in mind. We were. Every feature, every workflow, every record format exists because the regulation demanded it — not because it was convenient to build.
Our team includes former FDA investigators, Class III device quality directors, and QMSR regulatory specialists. When we say our 21 CFR Part 820 / QMSR Training Management platform is inspection-ready, we mean it from direct experience.
Our Story
Built by People Who Lived 21 CFR Part 820 / QMSR
Our founders spent a combined 30 years inside FDA-regulated device companies before writing a single line of code. They had witnessed first-hand what happens when 21 CFR Part 820 / QMSR Training Management records are incomplete at inspection time — 483 observations, Warning Letters, costly remediation programs, and shaken investor confidence.
The existing solutions were either overcomplicated enterprise platforms that took months to configure or simple LMS tools that understood training but not 21 CFR Part 820. Neither could reliably stand up to an FDA investigator's questions about personnel qualification.
A 21 CFR Part 820 / QMSR Training Management gap discovered by an FDA investigator costs a hundred times more to fix than a gap discovered by your own LMS the week before.
That insight became our founding principle. Today, over 480 medical device companies trust our 21 CFR Part 820 / QMSR Training Management platform to maintain the personnel qualification records that define their regulatory standing — from Class I startups preparing for initial FDA registration to Class III manufacturers managing global multi-site operations.
Our Values
What Drives Every Decision at Our 21 CFR Part 820 / QMSR Company
Regulatory Precision
21 CFR Part 820 / QMSR Training Management is not a place for approximation. Every feature we build is traceable to a specific regulatory requirement — we never add capability for its own sake without confirming the regulatory basis first. This keeps our platform lean, purposeful, and defensible.
Inspection Readiness Always
Our 21 CFR Part 820 / QMSR Training Management platform is designed as if FDA investigators are on-site every day. Documentation is always current, always exportable, always defensible.
QMSR Evolution Commitment
As the FDA continues to evolve the QMSR framework, our 21 CFR Part 820 / QMSR Training Management platform evolves with it — proactively, not reactively.
Patient Safety at Center
21 CFR Part 820 / QMSR Training Management exists to ensure competent people build safer devices. This moral purpose anchors every platform decision we make.
Intelligent Automation Without Compromise
We automate everything that can be automated in 21 CFR Part 820 / QMSR Training Management — SOP change notifications, training assignments, effectiveness verification, record archival — while preserving the human judgment and oversight that regulation requires at every critical decision point.
Leadership
The Team Behind 21 CFR Part 820 / QMSR Training Management
Former FDA investigator turned quality technology entrepreneur. James spent 12 years conducting 21 CFR Part 820 / QMSR inspections before founding this company to solve the training records problem from the inside.
18 years as VP Quality at Class II and Class III device companies. Rena has personally managed 21 CFR Part 820 / QMSR Training Management programs through 40+ FDA inspections — she built our platform's compliance logic.
Regulatory software architect with expertise in 21 CFR Part 11 compliant systems. Thomas designed the data integrity architecture that makes our 21 CFR Part 820 / QMSR Training Management records FDA-defensible at every layer.
Our History
A Decade of 21 CFR Part 820 / QMSR Focus
From a two-person startup to the industry's leading 21 CFR Part 820 / QMSR Training Management platform — our journey has always followed the regulation.
Company Founded
Two former FDA investigators built the first prototype of a 21 CFR Part 820 / QMSR Training Management system that could withstand the scrutiny of an actual FDA inspection — because they knew exactly what investigators look for.
First 100 Clients Reached
Our 21 CFR Part 820 / QMSR Training Management platform reached 100 medical device company customers after three consecutive 0-observation FDA inspection cycles across our client base.
21 CFR Part 11 Compliance Layer Added
Full electronic signature and audit trail infrastructure integrated, making our 21 CFR Part 820 / QMSR Training Management records fully compliant with 21 CFR Part 11 requirements for electronic records in regulated industries.
QMSR Update Integration
Rapid platform update following the FDA's QMSR rulemaking aligned our 21 CFR Part 820 / QMSR Training Management system with the new ISO 13485:2016 alignment requirements — clients received compliance updates before the rule took effect.
Our Mission
To eliminate every 21 CFR Part 820 / QMSR Training Management deficiency before an FDA investigator ever has the chance to find one. We exist to make training record gaps a thing of the past for every FDA-regulated device company — from first-in-human startups to global top-tier manufacturers running thousands of qualified personnel across dozens of sites.
Our Vision
An FDA-regulated medical device industry where 21 CFR Part 820 / QMSR Training Management is a strength, not a vulnerability. Where every quality team can walk into any FDA inspection with total confidence in their training records — and where no patient is ever harmed because a device was built or serviced by someone whose qualification gaps went undetected.