Design Assurance & Risk
Risk files that stay current while the design changes.
Design Quality Engineers, risk management owners and usability leads keeping the design history and risk file aligned under ISO 13485:2016 §7.3 and ISO 14971:2019.
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 FMEA is updated at the design review, then goes stale until the next one.
- Failure-mode brainstorming depends on who is in the room.
- Risk controls, verification evidence and CAPAs point at each other through document numbers typed by hand.
- Design-change impact on the risk file is assessed from memory.
Your week with VirtualBackroom
- The FMEA worksheet proposes failure modes from a three-model council for your engineers to accept, edit or reject, and keeps an append-only history of every change.
- Risk lines link to CAPAs, and the RPN matrix recolours as controls are added.
- Council Mode answers design-control and usability questions with citations to ISO 13485, IEC 62366-1 and the FDA QMSR, each one checked against the recognised clause formats and flagged when it cannot be verified.
- Warning Letter Insights shows what FDA cites on design controls today, not in the year your template was written.
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.
ISO 14971-aligned FMEA with AI-suggested failure modes, a colour-coded RPN matrix, CAPA cross-links and PDF/Excel export.
Three FMEAs on Free; unlimited on Pro.Open, investigate and close corrective actions with a hash-chained history, dual-control approvals, and links from the FMEA line, complaint, deviation, 8D case or exposure row that raised them.
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.
Every FDA medical-device warning letter, fetched daily, with deficiencies mapped to QMSR and ISO 13485 clauses.
Browser on Free; bulk analysis on Pro.Browse every standard the platform can cite, with the clause formats the citation validator accepts.
Requirements this role answers to
- ISO 13485:2016 §7.3 — Design and development
- ISO 13485:2016 §7.3.9 — Control of design and development changes
- IEC 62366-1 §5.7 — Usability engineering: user interface specification
- AIAG-VDA FMEA Handbook — FMEA method (DFMEA / PFMEA)
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.
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.