| Product fit | Confirm the pump’s intended arthroscopic procedures, pressure and flow controls, alarm functions, and compatibility with the required tubing and accessories. | Current instructions for use, technical specifications, accessory list, and compatibility information. | Which tubing sets and accessories are validated for use with the offered pump? |
| Regulatory status | Check authorization and market-access requirements for the destination country and the specific device configuration. Requirements vary by jurisdiction and device classification. | Applicable market authorization or conformity documents, device labeling, and the manufacturer’s regulatory contact details. | What documentation is available for the exact model being quoted and the intended destination market? |
| Quality management | Assess whether the manufacturer maintains a quality system appropriate to medical-device design and production. A quality-system certificate does not by itself establish product authorization. | Current quality-management-system certificate, issuing body details, scope, and validity dates. | Does the certificate scope cover the relevant manufacturing site and device activities? |
| Supplier and factory verification | Distinguish the legal manufacturer from a distributor or trading intermediary, and verify the production and service locations. | Business registration details, manufacturer declaration, site information, and a documented supplier audit or assessment where appropriate. | Who is the legal manufacturer, and who is responsible for complaints, repairs, and regulatory communications? |
| Global shipping and import | Agree on shipping terms, packaging, export documents, delivery responsibilities, and importer obligations. Customs classification and import requirements should be confirmed for each destination. | Commercial invoice, packing list, transport documents, country-of-origin information, and agreed Incoterms® rule. | Who arranges freight, insurance, customs clearance, and delivery to the final site? |
| Installation and training | Establish whether commissioning, user training, and service training are offered locally or remotely, and in which languages. | Installation checklist, training materials, service procedures, and a written statement of included services. | Are installation and training included, and what are the response arrangements if on-site support is needed? |
| Warranty and repairs | Review warranty duration, exclusions, service turnaround expectations, repair location, and responsibility for shipping during repairs. | Written warranty terms, service contact details, repair process, and any available loaner-equipment policy. | Where will repairs be performed, and how are downtime and replacement parts handled? |
| Spare parts and consumables | Check the availability, ordering process, storage requirements, and expected supply continuity for compatible accessories and consumables. | Parts catalogue, consumables list, shelf-life information where applicable, and written supply terms. | Which items are single-use, and how can buyers confirm ongoing availability and compatibility? |
| Traceability and post-market support | Confirm processes for recording device identifiers, handling complaints, communicating safety notices, and supporting applicable post-market obligations. | Device labeling and identifier information, complaint procedure, and documented safety-notice communication process. | How will the supplier notify the buyer of product updates or safety-related communications? |