| Regulatory Status | Whether the exact syringe pump model is legally registered for the target market. | For China, verify the applicable NMPA registration or filing. For Europe, confirm compliance with Regulation (EU) 2017/745 where applicable. For the United States, verify the correct FDA pathway before making market-access claims. | Registration certificate, declaration of conformity, product classification, official database record, and current product labeling. | 15% | 5 = Exact model and target market fully documented; 1 = Only general company certificates. |
| Quality Management System | Effectiveness and scope of the supplier’s medical-device quality system. | ISO 13485 certification should cover the manufacturing site, relevant device category, and applicable design or production activities. Check certificate validity and certification scope. | Current ISO 13485 certificate, audit body details, scope statement, corrective-action records, and quality agreement. | 12% | 5 = Valid, relevant, independently verifiable system; 1 = Certificate unavailable or scope mismatch. |
| Electrical and Functional Safety | Electrical safety, essential performance, alarm behavior, and protection against foreseeable misuse. | Testing should address IEC 60601-1 and the particular requirements of IEC 60601-2-24 for infusion pumps and controllers, when applicable to the product configuration. | Recognized laboratory test reports, CB Scheme documentation where available, risk-control records, and alarm test results. | 12% | 5 = Complete model-specific reports; 1 = Self-declaration without technical evidence. |
| Flow-Rate Performance | Accuracy and stability across the declared syringe sizes and operating conditions. | Do not compare flow-rate figures alone. Confirm the declared minimum and maximum rates, start-up behavior, bolus characteristics, occlusion recovery, and accuracy under representative syringe types, temperatures, and back pressures. | Model-specific performance curves, test protocol, raw data, syringe compatibility list, and acceptance limits. | 12% | 5 = Repeatable data across the full claimed operating range; 1 = Only a single nominal value. |
| Syringe Compatibility | Mechanical fit and reliable operation with the intended syringe sizes and manufacturers. | Verify the supported syringe brands, sizes, graduations, materials, flange geometry, and automatic recognition method. Compatibility must be validated rather than inferred from barrel volume alone. | Compatibility matrix, mechanical drawings, validation reports, user instructions, and sample testing records. | 10% | 5 = Broad, validated matrix with clear exclusions; 1 = Compatibility based only on marketing statements. |
| Alarm and Safety Functions | Detection of occlusion, empty syringe, near-end, end-of-infusion, power failure, door or clamp problems, and incorrect loading. | Each alarm should have a defined trigger condition, visual and audible indication, user response, and safe-state behavior. Occlusion thresholds should be specified for relevant flow rates. | Alarm specification, verification records, risk analysis, user manual, and demonstration video or witnessed test. | 10% | 5 = Complete, tested, and clearly documented; 1 = Basic alarm list without thresholds or verification. |
| Software and Cybersecurity | Software lifecycle controls, data integrity, access control, and protection of connected functions. | For software-controlled medical devices, assess IEC 62304 processes where applicable, usability engineering under IEC 62366-1, update control, user authentication, and network-security risk management for connected models. | Software architecture summary, version history, cybersecurity policy, vulnerability response process, usability file, and release records. | 8% | 5 = Controlled lifecycle and documented security process; 1 = No software-change or vulnerability procedure. |
| Biocompatibility and Materials | Safety of patient-contacting or fluid-path materials and resistance to cleaning agents. | For patient-contacting materials, evaluate the applicable biological safety endpoints under ISO 10993 based on contact type and duration. Confirm that materials are suitable for the intended clinical environment. | Material declarations, supplier certificates, biological evaluation, chemical compatibility data, and cleaning or disinfection instructions. | 6% | 5 = Material and biological evaluation are traceable; 1 = Generic material names only. |
| Manufacturing and Traceability | Process control, incoming inspection, calibration, batch records, and serial-number traceability. | Critical components should have defined acceptance criteria. Measuring equipment must be calibrated, and finished devices should be traceable to production records and release inspection. | Factory audit report, process flow, inspection plan, calibration certificates, device history records, and traceability procedure. | 6% | 5 = Full traceability and controlled production; 1 = Assembly capability cannot be verified. |
| After-Sales Support | Technical service, spare parts, training, warranty handling, and complaint response. | Require written response-time targets, spare-parts availability, service training, preventive-maintenance instructions, complaint handling, and field-safety escalation procedures. | Service-level agreement, warranty terms, spare-parts list, training plan, complaint procedure, and service network description. | 5% | 5 = Measurable support commitments; 1 = Informal or undefined support. |
| Commercial Reliability | Delivery consistency, customization control, capacity, and financial or operational stability. | Evaluate lead time using a written production schedule, not a verbal estimate. Confirm minimum order quantity, engineering-change notification, production capacity, and continuity plan. | Capacity statement, purchase-contract terms, delivery history, change-control procedure, business-continuity plan, and reference projects without confidential details. | 4% | 5 = Transparent and contractually controlled; 1 = Unclear capacity or repeated undocumented changes. |