A missed MDR deadline is a federal violation. An untrended complaint pattern is the next product recall. Affinity QMS Complaint Management handles the entire complaint lifecycle — from intake through reportability determination, CAPA linkage, and customer communication — with MDR timeline tracking built in for medical device manufacturers.
FDA MDR Reporting Timelines — Tracked Automatically
30
Days — Malfunction reports (21 CFR Part 803.50)
30
Days — Death and serious injury (21 CFR Part 803.50)
5
Business days — Remedial action requiring device removal (803.53)
Affinity QMS tracks each MDR-eligible complaint against its regulatory deadline and alerts QA leadership as deadlines approach.
Configurable Complaint Intake Form
Complaint intake fields are configurable by vertical — medical device complaints capture lot number, device model, patient impact, and event description; food complaints capture product code, distribution dates, and illness indicators. Required fields enforce complete intake documentation before a complaint can be saved.
Adverse Event and MDR Determination Workflow
A guided decision tree walks investigators through MDR reportability determination — death, serious injury, or malfunction that could cause harm. Each determination is documented with the regulatory rationale. Non-reportable determinations are also recorded with justification — protecting you during FDA audits of your complaint files.
CAPA Linkage in One Click
When a complaint requires corrective action, initiate a linked CAPA record directly from the complaint. The complaint record, investigation findings, and CAPA are cross-referenced automatically. Auditors see the complete chain from complaint receipt to root cause analysis to corrective action closure — in a single record view.
Complaint Trending by Product, Lot, and Issue Type
Aggregate complaint data to surface patterns before they become systemic failures. Trending charts show complaint frequency by product line, lot number, complaint category, and customer type. Spike alerts notify QA when a product's complaint rate exceeds your defined threshold — enabling preventive action before FDA notices.
30/45/90-Day MDR Timeline Tracking
For each MDR-eligible complaint, Affinity QMS tracks the regulatory deadline and displays days remaining to reporting. Color-coded status indicators show green, amber, and red as deadlines approach. Automated notifications go to the designated MDR contact — eliminating the spreadsheet-based MDR log that misses deadlines.
Regulatory Reportability Decision Tree
Built-in decision logic for FDA MDR (21 CFR Part 803), FDA adverse event reporting for supplements (MedWatch), and voluntary reporting programs. The decision tree captures every branch of the determination — so investigators follow a consistent, defensible process regardless of experience level.
Complaint Closure and Customer Communication Tracking
Document all customer communications — acknowledgment letters, investigation updates, resolution notices — within the complaint record. Track response dates and communication method. Complaint closure requires all required fields completed and a final response documented — producing a complete complaint file that satisfies 21 CFR Part 820.198.
| Regulation / Standard | Clause / Section | Complaint Management Coverage |
|---|---|---|
| 21 CFR Part 820.198 | Complaint Files | Complaint intake, investigation, MDR determination, CAPA linkage, closure documentation |
| ISO 13485:2016 | Clause 8.2.2 — Complaint Handling | Complaint handling process, regulatory notification assessment, investigation records |
| 21 CFR Part 211.198 | Complaint Files (Drug Products) | Written procedures, investigation records, review and evaluation of complaints |
| 21 CFR Part 803 | Medical Device Reporting (MDR) | Reportability determination, 30/5-day timeline tracking, MDR submission records |
| FDA QMSR (2024) | 820.200 — Complaint Files | Complaint review, investigation, MDR evaluation, record maintenance |
| 21 CFR Part 111 | Subpart O — Returned Dietary Supplements | Consumer complaint investigation, product return evaluation, distribution records |
Included in Builder — Starting at
$799/mo
Complaint Management is included in the Builder tier ($799/mo) and all tiers above it. MDR timeline tracking and reportability decision trees are included — no add-ons required.
Book a demo and see how Affinity QMS tracks every complaint from intake to closure — with MDR timelines, reportability decisions, and CAPA linkage in one place.