Regulatory Affairs
Cited answers across FDA, EU MDR and ISO without re-reading the regulation every time.
Regulatory Affairs specialists and managers responsible for FDA, EU MDR and ISO 13485 strategy, submissions support and regulatory intelligence.
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
- The same clause question gets researched three times by three people, and the answer lives in someone's notes.
- Regulatory change monitoring means a dozen bookmarked pages and a newsletter backlog.
- Cross-walking a requirement between the FDA QMSR, ISO 13485 and EU MDR is manual every time.
- Nobody can show an auditor how a regulatory position was reached, or when.
Your week with VirtualBackroom
- Council Mode puts one question to a council of models and returns cited answers side by side, with a consensus score and a citation check that marks each citation verified or unverified. Nothing is auto-approved: the answer is a draft for your review.
- The regulatory assistant logs every question and answer to an audit trail, so a position has a date and a source.
- Regulatory radar collects relevant changes in one feed; Pro users set custom alerts for the standards they own.
- The Standards Library shows exactly which standards and clause formats the platform can cite, so there are no surprises.
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.
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.
Cited answers to regulatory questions, each logged to the AI audit trail for later review.
Metered on Free; unlimited on Pro.A feed of regulatory changes relevant to device and supplier quality programs.
Browse on Free; custom alerts on Pro.Browse every standard the platform can cite, with the clause formats the citation validator accepts.
Every FDA medical-device warning letter, fetched daily, with deficiencies mapped to QMSR and ISO 13485 clauses.
Browser on Free; bulk analysis on Pro.Visual maps of how regulations, standards and QMS processes connect.
Requirements this role answers to
- EU MDR Article 10 — General obligations of manufacturers
- EU MDR Article 83 — Post-market surveillance system
- ISO 13485:2016 §4.2.3 — Medical device file
- FDA QMSR (21 CFR Part 820) — Quality management system regulation
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 where you stand today
New accounts are paused at the moment. The free Exposure Check still runs without one, and the self-service demo shows the whole QMS OS on sample data.
Need the regulation as files, with the former-QSR-to-ISO 13485 crosswalk, Part 11 / Annex 11 and the regulatory map for twelve jurisdictions? 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.