| Supplier identity and manufacturing capability | Confirm the supplier’s registered business scope and whether it manufactures the products, subcontracts production, or acts as a trading company. Check that the factory address and product range match the supplier’s claims. | Business registration information, factory address, production-process overview, equipment list, and a live or independent factory audit. | Positive: Production responsibilities and subcontractors are clearly disclosed. Warning: Factory access is refused or manufacturing claims cannot be verified. |
| Quality management system | For medical devices, check whether the quality system is appropriate to the product and destination market. ISO 13485 concerns quality management systems for medical devices; it does not by itself prove that every product is safe or compliant. | Current certificate, issuing and accreditation details, certificate scope, covered manufacturing site, and audit or corrective-action records where available. | Positive: The certificate scope and site match the product being quoted. Warning: A certificate is expired, out of scope, or presented as a substitute for product-specific regulatory evidence. |
| Regulatory status for the destination market | Determine the device’s classification and applicable requirements in the intended sales market. Requirements vary by product type and jurisdiction. For example, EU market access may involve the EU Medical Device Regulation (MDR), while China-market devices may require applicable NMPA registration or filing. | Product classification rationale, applicable registration or certificate documents, declaration of conformity where required, and confirmation that the documents cover the exact model and manufacturer. | Positive: Documents can be checked with the relevant authority or issuing body. Warning: A supplier makes a blanket compliance claim without identifying the product, market, or applicable route. |
| Claims for EU and U.S. markets | Check the rules for the specific device. CE marking under the EU MDR applies where required; the need for notified-body involvement depends on the device and conformity-assessment route. In the United States, FDA registration or listing is not the same as FDA approval. | Applicable EU declaration and certificates, notified-body details when relevant, and U.S. clearance, authorization, or listing information as applicable to the device. | Positive: The supplier distinguishes registration, listing, clearance, authorization, and certification. Warning: “FDA approved” is used as a generic claim without verifiable product-specific support. |
| Technical specifications and intended use | Compare product specifications against the clinical task and purchasing requirements. For powered equipment, review items such as rated voltage, frequency, power, operating limits, and included accessories. For hand instruments, define dimensions, working ends, and intended use. | Controlled specification sheet, instruction for use, model and configuration list, drawings where relevant, and a written list of included accessories. | Positive: Specifications are complete, consistent across documents, and tied to a specific model. Warning: Key parameters change between quotation, sample, and final order. |
| Materials and product safety | For patient-contacting products, establish which materials contact the patient and evaluate them according to the device’s intended use and applicable requirements. Material suitability and biological evaluation are product-specific; a material name alone is not proof of safety. | Material specifications or certificates, supplier declarations, risk-management documentation, and relevant biological-safety evaluation where applicable. | Positive: Materials and patient-contact areas are clearly identified and traceable. Warning: The supplier cannot identify materials or relies only on unsupported terms such as “medical grade.” |
| Sterilization and reprocessing | Confirm whether the product is supplied sterile or intended for cleaning, disinfection, or sterilization before reuse. Check that the validated instructions match the product and the sterilization method; standards such as ISO 17665 may be relevant to moist-heat sterilization. | Instructions for use, validated sterilization or reprocessing information where applicable, packaging information for sterile products, and relevant process-validation records. | Positive: Instructions specify compatible methods and operating conditions. Warning: The product is claimed to be reusable or sterile without clear supporting instructions or validation. |
| Electrical and mechanical safety | For powered dental equipment, check applicable electrical-safety and electromagnetic-compatibility requirements. IEC 60601-1 may apply to medical electrical equipment, together with relevant particular standards where required. Confirm that test reports cover the exact model and configuration. | Applicable test reports, model identification, electrical ratings, risk-management documents, and maintenance or installation requirements. | Positive: Reports identify the tested product and applicable standards. Warning: Reports refer to a different model or only cover an unrelated component. |
| Performance testing and sample inspection | Request representative samples and evaluate them against predetermined acceptance criteria. Check fit, finish, operation, noise or vibration for powered items, and consistency between sample and production specifications. | Inspection checklist, functional-test results, sample identification, product photographs, and documented acceptance criteria. | Positive: Sample results are repeatable and match the approved specification. Warning: Only selected samples are offered, or production tolerances are not defined. |
| Traceability and change control | Check whether products can be traced through production and whether changes to materials, components, manufacturing sites, or specifications are controlled and communicated. | Lot or serial-number examples, batch records where applicable, supplier-change procedure, and written change-notification terms. | Positive: Model and lot identification support investigation of quality issues. Warning: The supplier cannot explain how affected products would be identified after a defect is reported. |
| Packaging, shipping, and storage | Check whether packaging protects the product during the expected shipping route and whether storage conditions are specified. Sterile-barrier packaging requirements depend on the product and applicable regulatory route. | Packaging specifications, labeling samples, storage and transport conditions, and packaging validation information where applicable. | Positive: Labels, model details, and handling instructions match the order. Warning: Packaging or labeling is changed without documented review. |
| Warranty, service, and spare parts | Clarify warranty coverage, service response, maintenance requirements, spare-parts availability, and responsibility for installation or training, especially for powered equipment. | Written warranty terms, service procedure, parts list, maintenance schedule, and response-time commitments. | Positive: Terms are specific to the product and market. Warning: Support promises are verbal, exclusions are unclear, or essential replacement parts are unavailable. |
| Commercial terms and order controls | Compare quotations using the same model, configuration, quantity, delivery terms, packaging, and documentation requirements. Set inspection and approval requirements before production. | Itemized quotation, purchase specification, agreed sample, inspection plan, delivery terms, and written procedures for nonconforming products. | Positive: The quotation and purchase specification describe the same product. Warning: A low price depends on unclear substitutions or undocumented changes. |
