Short answer: verify the exact model, intended use, evidence, and production controls—not only the company profile. A reliable import file connects every commercial claim to a document, test, responsible party, and change-control requirement.
1. Separate company checks from product checks
| Company due diligence | Product due diligence |
|---|---|
| Legal entity, address, export history, ownership, references | Model identity, intended use, specifications, drawings, nameplate |
| Quality responsibilities and complaint process | Temperature, electrical, alarm, energy, and environmental evidence |
| Capacity, key processes, subcontractors, change control | Applicable registration, standards, labelling, manuals, traceability |
| Warranty resources and spare-parts channel | Inspection plan, acceptance limits, service parts, configuration control |
2. Verify regulatory language precisely
Ask which legal requirement applies to the exact product and destination. Request the certificate or database record, model scope, issuing body, validity, and underlying test report where relevant. FDA explicitly states that establishment registration or device listing does not denote approval of the establishment or product. Avoid converting “registered” into “FDA approved” in marketing or tender files.
3. Request model-specific performance evidence
- Temperature uniformity, stability, and recovery test conditions and results.
- Alarm list, set-point permissions, data export, remote contacts, and controller manual.
- Electrical ratings, safety evidence, refrigerant details, and ambient operating limits.
- Dimensions, usable layout, shelf loads, packaging, net and gross weights.
- Warranty terms, exclusions, spare-parts prices, and diagnostic process.
4. Approve a golden sample and inspection plan
Record the approved model, controller, compressor, sensors, shelves, doors, voltage, plug, labels, manuals, accessories, and packaging. Define incoming, in-process, and final inspection points. For critical temperature performance, agree how a representative production unit will be tested and what constitutes acceptance.
5. Control commercial and logistics risk
Align the quotation, purchase order, pro forma invoice, packing list, and shipping marks to the same model configuration. State the Incoterm and named place, production and inspection milestones, document deadlines, insurance responsibility, packaging requirements, and process for nonconformity. Confirm whether batteries, refrigerants, data devices, or wooden packaging create transport or import requirements.
6. Make after-sales support measurable
Define the warranty start point, response target, diagnostic information, freight and labour responsibility, critical spare-parts package, and support for repeat orders. Require notice before changes to key components, firmware, materials, labelling, or manufacturing location.
Supplier comparison scorecard
- Application fit and usable capacity: 20%
- Temperature and alarm evidence: 25%
- Regulatory and documentation fit: 20%
- Service, parts, and change control: 20%
- Commercial and delivery terms: 15%
Adjust the weights to project risk and record the evidence behind every score. Contact Roundfin with the completed brief to compare the current medical cold-storage range.