Orange County, California & Remote
One partner for quality, IT, and operations.
Medical device startups and small businesses carry a big-company regulatory footprint on a small-company headcount. Red Hen Admin is the partner that covers it: FDA QMSR compliance and ISO 13485 consulting, independent internal and supplier audits, practical IT support, and the administrative operations that keep it all running — without hiring a department for each.
Led by a certified Lead Auditor for ISO 13485, ISO 9001, and ISO/IEC 42001, serving teams of fewer than 100 employees — on-site in Southern California and remotely everywhere else.
The problem we solve
Small team. Big regulatory footprint.
The FDA QMSR took effect February 2, 2026, making ISO 13485 the law for every device manufacturer selling in the US — and FDA’s first hundred-plus inspections show the agency is checking. At the same time, your investors expect lean headcount, your IT needs to be secure enough for regulated data, and someone still has to keep documents controlled, records filed, and the day-to-day moving.
Most startups solve this with a patchwork: a compliance consultant here, an IT vendor there, and a founder doing admin at midnight. Red Hen Admin replaces the patchwork with one accountable partner who already understands how quality, IT, and operations fit together in a regulated company.
What we do
Four capabilities, one point of contact
Management System Consulting
FDA QMSR compliance, ISO 13485 and ISO 9001 implementation, gap analysis, remediation, and certification prep — from your first quality manual to inspection readiness.
Management Systems Auditing
Independent internal audits, second-party supplier audits, and pre-certification gap assessments for ISO 13485, ISO 9001, and ISO/IEC 42001 — objective, thorough, and free from consulting bias.
IT Support & Consulting
Practical, no-nonsense IT for small regulated businesses — day-to-day support, infrastructure planning, cloud services, and the security your quality records deserve.
Administrative Support
Document management, process improvement, and data entry — the operational load handled with the same care your quality system gets.
Candor · by Red Hen Admin
Audit-ready all year, without the December scramble
Candor is our managed internal-audit program: quarterly audits on a documented, risk-based schedule, every finding tracked to closure with effectiveness verification, and management-review inputs generated as you go. It turns the internal audit requirement from an annual fire drill into a quiet, standing habit. It changes the once-a-year scramble to find an auditor to a year long partnership with a certified auditor. It also allows you to track all of your audits and inspections in one place instead of six different locations.
Why Red Hen
Senior expertise, small-company scale
Credentialed, not just experienced
Certified Lead Auditor for ISO 13485:2016, ISO 9001:2015, and ISO/IEC 42001:2023, trained to ISO 19011 — with 6+ years inside regulated medical device environments.
Built for under-100-employee companies
No big-firm overhead, no junior staff learning on your dime. Fixed-scope engagements and programs priced for startups — a fraction of a full-time hire.
Systems thinking, not silos
Your QMS lives in your IT, and both run on daily operations. One partner who works across all three means nothing falls between vendors.
Want the receipts? Read The Slop — our clause-by-clause walkthroughs of the QMSR, ISO 13485, and ISO/IEC 42001 — or take the free QMSR Exposure Score self-assessment built from FDA’s first 100+ QMSR inspections.
Tell us what’s on your plate.
A free, no-strings consultation — we’ll tell you honestly what needs a consultant, what needs an auditor, and what you can fix yourself.