Founders & Executives
Understand your regulatory exposure before you hire for it.
Founders, CEOs and COOs of device start-ups and small manufacturers who own the quality system before there is a quality department.
Your week, before and after
The left column is how this work usually gets done. The right column is the same week with the records, evidence and reminders living in one place.
Your week today
- You know a QMS is required and have no independent read on how far off you are.
- Quotes from consultants start from scratch because nobody has mapped the gaps.
- Investors and partners ask about regulatory status and get a feeling, not a position.
- The first inspection is also the first rehearsal.
Your week with VirtualBackroom
- The free QMSR Exposure Check gives you a deterministic, per-area read on where your company is exposed, with no account and no upload.
- The Compliance Exposure dashboard separates inherent exposure (what your product and market imply) from residual exposure (after your current posture), so you can see what is actually reducing risk.
- Audit Coach lets you or your first quality hire rehearse an inspection with an AI investigator before the real one.
- When you do bring in help, the Gap Analysis PDF gives a consultant a scoped starting point instead of a blank page.
The tools behind it
Every tool links to its real page. Tools marked Pro or Premium need that plan; everything else works on a free account. Compare plans.
QMSR Exposure Check No login needed
A deterministic read on where a device company is exposed under the FDA QMSR, with a per-area report. No account needed.
Inherent vs. residual exposure for your company, re-scored as your posture answers change.
CAPA hand-off and PDF export on Pro.Practice FDA-style and ISO inspections against an AI investigator, with scored debriefs and weakness reports.
Three simulations a month on Free; unlimited on Pro.Upload procedures across 28 QMS document types and get a readiness score, missing clauses, and a board-ready PDF.
Overview depth on Free; full analysis on Pro.Self-service product demo No login needed
A guided tour of the QMS OS with sample data. Nothing to install, nothing to upload.
Requirements this role answers to
- FDA QMSR (21 CFR Part 820) — Quality management system regulation
- ISO 13485:2016 §5.1 — Management commitment
- EU MDR Article 10 — General obligations of manufacturers
Citations use the clause formats listed in our Standards Library. The FDA QMSR is cited at the Part level; withdrawn 21 CFR 820 subsections are never presented as current requirements.
Start with the free Exposure Check
No account and no upload. You get a per-area read on where your company is exposed under the FDA QMSR, and a clear picture of what the rest of the platform would add.
Other roles
What this page does not claim. VirtualBackroom.ai is advisory and training software. It does not replace your procedures, your regulatory counsel or an independent audit, and AI output is a draft for qualified human review. Deterministic tools (quality statistics, exposure scoring) are labelled as such; where a figure is not produced by one of them, we do not quote one. Plan tiers shown here reflect the current pricing. Read our AI Boundaries and Security pages for the full intended-use statement.