BEFORE YOU COMPARE SUPPLIERS
Three gaps to close before the next commitment.
1. A company certificate is presented as product authorization
A supplier sends a quality-system certificate or an establishment registration, then describes the device as approved. The document may concern the organization rather than the product, market route or particular device you intend to purchase.
We record what the document actually states, the named entity and scope, and the supplier claim attached to it. Where issuer or regulator records are available, the agreed review identifies the reference and any match or discrepancy.
The record: The register labels organizational evidence, product-specific evidence and unverified claims separately. Your regulatory reviewer decides the required authorization route and whether additional evidence is necessary.
2. A report covers a different model or configuration
A test report may describe another accessory, power supply, material, software version or model suffix. An abbreviated PDF can omit the annex that explains which configurations were assessed.
We request the full document and relevant annexes, compare the product identifiers with the proposed quotation and sample, and ask the supplier to explain any claimed model-family coverage.
The record: A model-to-document matrix shows exact matches, differences and unsupported extensions. It gives you a defined list of clarifications before accepting the proposed configuration.
3. OEM branding and responsibilities remain undefined
The quoted seller, actual manufacturer and name planned for the label may differ. Buyers can also discover late that labeling files, instructions or post-sale support are outside the quoted arrangement.
We ask the parties to identify their roles, the proposed label and instructions, records to be supplied and responsibility for requested changes. Legal or regulatory responsibilities are referred to the appropriate adviser.
The record: A responsibility and open-items list makes the unresolved commitments visible before private-label artwork, samples or an order are authorized.
Put the evidence beside the requirement.
| Item | Match to establish | Open decision |
|---|---|---|
| Manufacturer identity | Entity on quote, label and supporting records | Confirm the proposed transaction parties |
| Product evidence | Exact model, configuration and intended use | Ask for missing scope or annexes |
| OEM arrangement | Brand, artwork, instructions and responsibilities | Approve the agreed route before commitment |
A defined piece of procurement work.
Zhipact coordinates one defined supplier-document review from Shenzhen. We turn your requirements into a document request, compare the responses and separate supported information from claims and missing items. The output helps your appointed regulatory or technical reviewer decide what to investigate next; it is not a substitute for market authorization or an independent conformity assessment.
- Eddie leads the requirements review and supplier decisions. Coordination colleagues request records, maintain the comparison and follow up open items. Any physical check or specialist assessment has a named provider, method and deliverable. You approve the scope, fees and next commitment before work begins.
- The quote states which records and sources are reviewed, supplier follow-up rounds, reporting format and timing. Translation, issuer confirmation, specialist review or a site visit can be scoped separately when needed. Supplier documents remain identified by source and date; receiving a file does not establish its validity.
Your next decision: Use the review to request specific evidence, arrange a specialist assessment, select a sample route or pause the proposal. Finding an apparent manufacturer is only one part of deciding whether the device and commercial arrangement fit your requirements.
Questions before you enquire.
Does FDA registration mean a device is FDA approved?
No. Registration or listing is not itself FDA approval. The applicable pathway depends on the actual product and intended use. We record the evidence supplied and the claim made so your regulatory reviewer can assess the correct requirement.
Can this task cover destinations outside the United States?
Yes. State the destination and the requirements identified for that product. We organize the supplier request around those inputs rather than treating a US registration or a CE reference as universal permission to sell.
Official references for the stated market
Check the current requirements for the exact product, use and destination. These references support the document questions above; they do not establish approval of a supplier or product.