| Product selection |
Does the store offer equipment suited to the intended setting, user, and clinical need—for example, mobility aids, monitoring devices, respiratory equipment, or examination supplies? |
Clear specifications, intended-use information, size or configuration options, and guidance on whether a clinician’s assessment or prescription may be needed. |
One-size-fits-all recommendations, unclear intended use, or claims that a product can diagnose or treat conditions without appropriate evidence. |
| Regulatory status |
Check the rules that apply in the country where the device will be supplied. Confirm the product’s status and the seller’s role where local rules require authorization or registration. |
Device and supplier details that can be checked with the relevant national regulator or official database. In the United States, establishment registration or device listing alone does not mean FDA approval or endorsement. |
Unverifiable regulatory claims, missing manufacturer or responsible-party details, or language implying that registration alone proves a device is approved. |
| Market-specific conformity |
For products placed on the EU market, check applicable Medical Device Regulation requirements and CE marking. The conformity-assessment route depends on the device and its risk classification. |
Where applicable, a Declaration of Conformity and information about the notified body involved in the assessment. Check that documentation matches the exact device and model. |
A generic certificate that does not identify the product, or a claim that every device requires the same conformity-assessment route. |
| Quality management |
Ask how the store controls sourcing, storage, order handling, complaints, and product recalls. Distinguish company quality-system certification from product authorization. |
Documented quality procedures and, where relevant, a current ISO 13485 certificate whose scope covers the organization’s applicable activities. |
Using an ISO 13485 certificate as proof that every product is approved, safe for every user, or independently tested. |
| Authenticity and traceability |
Confirm that products are new or clearly identified as refurbished, and that applicable lot, serial, expiry, and Unique Device Identification details are available. |
Accurate invoices and labels, traceable supply records, and a process for notifying customers about safety notices or recalls. |
Removed or altered labels, unexplained packaging, missing expiry information where relevant, or no way to trace the supplied item. |
| Product condition and storage |
Check packaging integrity, storage conditions, expiry dates for applicable products, and the store’s handling of sterile or temperature-sensitive items. |
Clear storage and shipping practices, intact packaging on delivery, and documented handling requirements when the product requires them. |
Damaged seals, unclear storage history, expired stock, or shipping methods that conflict with the product’s stated storage requirements. |
| Training and support |
Find out whether staff can explain setup, safe use, cleaning, maintenance, and limitations—or can direct customers to qualified clinical support when appropriate. |
Accessible instructions for use, training options, and clear contact routes for technical or product questions. |
Advice outside staff competence, pressure to replace clinical guidance, or no instructions for safe setup and use. |
| Service and maintenance |
For equipment requiring servicing, calibration, or repair, check who performs the work, expected turnaround times, and whether loan equipment is available if needed. |
Written service terms, maintenance schedules where applicable, qualified service personnel, and access to required parts or accessories. |
Unclear repair responsibility, no service records for maintained equipment, or unsupported claims that calibration is never necessary. |
| Warranty, returns, and total cost |
Compare the full cost, including delivery, installation, consumables, accessories, servicing, and any applicable return restrictions for opened or custom products. |
Written warranty and return terms, itemized pricing, and clear information about exclusions and ongoing costs. |
Hidden fees, vague warranty coverage, or return promises that conflict with applicable hygiene, safety, or consumer-protection requirements. |
| Overall decision |
Choose a store that can substantiate product claims, provide traceable goods, explain applicable requirements, and support safe use after purchase. |
Compare at least two suitable sellers using the same checklist and verify important regulatory details through official sources. |
Relying on price or online reviews alone when documentation, suitability, or after-sales support cannot be confirmed. |
