Customer complaint
Any written, electronic or oral communication alleging deficiencies in the identity, quality, durability, reliability, safety or performance of a marketed product.
21 CFR 820.198 and ISO 13485 §8.2.2 require a documented complaint-handling procedure: receipt, evaluation, investigation, determination of MDR reportability, response to complainant, and trend analysis. A complaint that meets the MDR criteria of 21 CFR 803 must be reported on the regulatory clock regardless of investigation status.
V5's complaint module links each complaint to the device UDI, the production lot, the operator, the equipment used, the DHR and any related NCR/CAPA — so the investigator opens one record and sees the entire chain of evidence.
- 21 CFR 820.198
- ISO 13485 §8.2.2
- 21 CFR 211.198
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