Complaints & Post-Market Surveillance
Every complaint logged, screened and visible in the Management Review.
Complaint handling units, post-market surveillance leads and vigilance owners under ISO 13485:2016 §8.2.2 and EU MDR Article 83.
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
- Complaints are logged in a shared mailbox and summarised quarterly by hand.
- Reportability decisions are made the same way each time, but documented differently each time.
- Trending happens when someone has a free afternoon.
- The Management Review complaint slide is assembled the night before.
Your week with VirtualBackroom
- The Complaint Log records each complaint with a server-computed MDR reportability screen and a reporting-clock countdown. It is an internal log: manual entry only, no external intake portal, and it does not submit reports to FDA.
- Recorded complaints flow into the Management Review as the feedback and complaint-handling inputs automatically.
- A complaint that needs corrective action can be linked to a CAPA in the same system, instead of a reference number in a spreadsheet.
- The Recall Effectiveness planner lets you prepare effectiveness checks by level before an event, not during one.
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.
An internal complaint log with MDR reportability screening and a reporting-clock countdown. Manual entry only; it is not an external intake portal and does not submit reports to FDA.
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.
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.
Plan recall effectiveness checks by level before you ever need one.
A feed of regulatory changes relevant to device and supplier quality programs.
Browse on Free; custom alerts on Pro.Requirements this role answers to
- ISO 13485:2016 §8.2.1 — Feedback
- ISO 13485:2016 §8.2.2 — Complaint handling
- ISO 13485:2016 §8.2.3 — Reporting to regulatory authorities
- EU MDR Article 83 — Post-market surveillance system
- EU MDR Article 87 — Reporting of serious incidents
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.