How to Evaluate an IVD Manufacturer

Direct answer: Evaluate an IVD manufacturer on four things — regulatory status (ISO 13485, CE, FDA listing, NMPA), product performance (sensitivity, specificity, datasheet), manufacturing quality (QC, validation, traceability), and documentation (COA, IFU, certificates). A supplier who can show the lot-specific evidence for each is the one that has de-risked your order.

The four evaluation dimensions

Regulatory status — ISO 13485 quality system; CE marking (with the conformity procedure and authorized representative); FDA establishment registration / device listing (not confused with 510(k) clearance); NMPA registration for China manufacture.
Product performance — analytical sensitivity, specificity, LoD and cut-off from the datasheet or validation report, not a marketing claim.
Manufacturing quality — QC per lot, batch release, raw-material traceability, stability data, retained samples.
Documentation — a lot-specific COA, IFU, and certificates in the supplier's own name.

Qualification checklist

Certificate: current, in the supplier's name, covering the products you buy.
COA: lot-specific, showing measured values — not a range copied from a catalogue.
Sensitivity / specificity / LoD: stated in the datasheet for the specific analyte.
Traceability: from raw material to finished lot, with retained samples.
CE conformity procedure: Annex III self-declaration vs Notified Body — know the difference.
FDA wording: "device listing" is not "510(k) cleared" — check which one is claimed.

Red flags that signal risk

No lot-specific COA — only a generic certificate or catalogue range.
"FDA on request" without a K-number or a clear listing statement.
No traceability from raw material to finished lot.
A certificate in a different company's name (broker reselling someone else's cert).

The Author's Take

Position: In my view, the single most useful test of an IVD supplier is whether they can produce a lot-specific COA and the performance datasheet for the analyte you are buying — not just a certificate wall.

Reasoning: A certificate proves the quality system; the COA and datasheet prove the product. An IVD buyer who accepts a certificate without the lot-level evidence has not reduced their regulatory or performance risk — they have described it. Ask for the number, not the logo.

Disclosure: This is my editorial view as an IVD manufacturer's regulatory team, not a contractual or legal statement.

By Progene Bio Regulatory Affairs Team · Medical disclaimer · Last reviewed: 2026-09-13