Quality Control Requirements
Direct answer: Quality control in rapid-test manufacturing means lot-level validation, internal control lines, and ISO 13485 traceability from raw material to finished device.
| QC element | What it means |
|---|---|
| Internal control line | Built into every device — confirms the test ran correctly |
| Batch validation | Each lot validated against reference methods |
| Lot records | Traceability from raw materials to finished-goods release |
| QMS | ISO 13485:2016 (GB/T 42061) quality management system |
| Raw material control | Antibody and membrane qualification before production |
For buyer qualification, request validation data, certificate of analysis (COA) and stability data — see the supplier evaluation checklist.
Frequently Asked Questions
What is the internal control line for? It validates each device, distinguishing a true negative from a failed test.
Related knowledge
References
- ISO 13485:2016 — Medical devices: Quality management systems.
By Progene Bio Regulatory Affairs Team · Medical Device QA · Medical disclaimer · Last reviewed: 2026-09-12