QMSR Is in Effect. Is Your QMS Ready?
The FDA’s QMSR replaced 21 CFR 820 on February 2, 2026. Every medical device company’s quality management system must now align with ISO 13485:2016 — and inspectors are already citing gaps. Red Hen helps small and mid-size device companies close those gaps before the FDA finds them.
QMSR Compliance Services
QMSR Gap Analysis
A systematic review of your current QMS against QMSR requirements. You get a prioritized gap report with specific actions — not a generic checklist. Typical turnaround: 2–3 weeks.
QMSR Compliance Sprint
A focused engagement to close your highest-risk QMSR gaps. Includes gap analysis, remediation planning, and hands-on implementation support. 4–8 week engagements starting at $4,500.
Fractional Quality Manager
Ongoing quality management support without a full-time hire. Ideal for startups and small device companies that need experienced QMS leadership on a part-time basis. Monthly retainers from $1,500.
Internal Audit Program
Managed internal audits through our Candor program. A certified lead auditor conducts your required audits on a set schedule — you get audit-ready without building an internal program from scratch. Starting at $3,000/year.
Why Red Hen
Certified Lead Auditor
Your work is led by a certified lead auditor with deep experience in ISO 13485 and FDA quality system requirements. Not a generalist — a specialist in the systems inspectors actually look at.
Built for Small Companies
Big consulting firms write proposals for big companies. Red Hen works with medical device companies that have 10–100 employees and need practical, right-sized quality systems that actually get used.
QMSR-Current
The QMSR took effect February 2, 2026. Red Hen has been tracking and writing about the transition since it was announced — we know the specific gaps inspectors are finding and how to close them.
AI Governance Ready
If your team is using AI tools — even for document drafting — you need a qualification framework before your next audit. Red Hen offers the only AI Use Qualification Toolkit built specifically for regulated medical device environments.
Not Sure Where You Stand?
Take the free QMSR Exposure Score — a 2-minute self-assessment that shows you exactly where your QMS has gaps under the new rule. No email required.
Talk to a Certified Lead Auditor
Book a free 30-minute call. We’ll review your QMSR exposure and give you a clear picture of what needs attention — no obligation, no sales pitch.