Quality & Regulatory Consultants
Scope engagements from evidence and leave clients with a system, not a binder.
Independent consultants and boutique firms serving device manufacturers and multi-standard suppliers.
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
- Every engagement starts with a manual gap assessment that eats the first week.
- Clients on different standards (ISO 13485, ISO 9001, IATF 16949, AS9100D) mean different checklists and different tooling.
- Deliverables are documents the client stops maintaining the day you leave.
- Answering "what does FDA actually cite?" means your own letter reading.
Your week with VirtualBackroom
- Multi-Standard Gap Analysis assesses one client QMS against ISO 13485, ISO 9001, IATF 16949, AS9100D and the FDA QMSR in a single pass.
- Warning Letter Insights and the daily corpus give you current enforcement evidence for proposals and training.
- Council Mode gives cited, comparable answers when a client asks for a position by Friday.
- Clients can keep working in the same CAPA, FMEA and Management Review tools after the engagement, with the audit trail intact.
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.
Assess one QMS against ISO 13485, ISO 9001, IATF 16949, AS9100D and the FDA QMSR in a single pass.
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.Every FDA medical-device warning letter, fetched daily, with deficiencies mapped to QMSR and ISO 13485 clauses.
Browser on Free; bulk analysis on Pro.Ask one regulatory question to a council of models from OpenAI, Anthropic, Google and Perplexity; compare their cited answers with a consensus score and per-citation verified/unverified flags.
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.Builds the ISO 13485:2016 §5.6 review record from data already in the platform and flags every required input that is still unaddressed. Never fabricates a number.
Requirements this role answers to
- ISO 13485:2016 §4.1 — QMS general requirements
- ISO 9001:2015 §9.3 — Management review
- IATF 16949:2016 §10.2.3 — Problem solving
- AS9100D §8.4 — Control of externally provided processes, products and services
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.
See the whole system in one sitting
The self-service demo walks through the QMS OS on sample data. Nothing to install, nothing to upload.
Need a dated, citable reference to carry into engagements, licensed per person so each consultant and each client holds their own copy? That is the QMSR Knowledge Pack, Edition 2026-11, a one-time purchase with no account needed.
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.