| Product Safety and Design Quality |
18% |
Frame stability, load capacity, adjustment range, emergency stop functions, pinch-point protection, surface finish, and user ergonomics. |
Technical drawings, risk assessment summary, product test reports, user manual, maintenance instructions, and sample inspection records. |
Safety features should be documented, repeatable in sample testing, and suitable for the intended patient population and clinical environment. |
Unclear load ratings, missing emergency procedures, inconsistent finishing, or specifications that change between documents. |
| Quality Management System |
12% |
How the supplier controls design changes, purchasing, production, inspection, complaints, corrective actions, and traceability. |
A valid ISO 13485 certificate issued by an accredited certification body, including the certified scope and site address. |
ISO 13485 certification should cover the relevant product category and the actual manufacturing or quality-control site. |
Expired certificates, mismatched legal entities, incomplete scope, or a certificate that covers only trading activities. |
| Regulatory and Certification Readiness |
12% |
Whether the proposed configuration can legally be placed on the target market and whether its technical file is complete. |
Declaration of Conformity, applicable conformity-assessment records, device classification rationale, labeling samples, and country-specific registration information. |
For applicable products, EU MDR documentation should support CE marking; U.S. requirements should be checked with the FDA device classification and listing rules. |
Claims that ISO 13485 alone proves product approval, unsupported CE logos, or statements that “FDA registered” means FDA approved. |
| Electrical and EMC Safety |
10% |
Electrical protection, leakage current, electromagnetic compatibility, power requirements, battery safety, and environmental operating limits. |
Applicable IEC 60601 test reports, EMC test results, power-supply specifications, battery documentation, and electrical safety inspection records. |
Electrical medical equipment should be evaluated against the applicable IEC 60601-1 and relevant collateral or particular standards. |
Generic laboratory reports with no model number, missing test configuration, or reports issued for a different product. |
| Risk Management and Usability |
8% |
Identification and control of hazards related to falls, incorrect adjustment, overloading, electrical use, cleaning, and foreseeable misuse. |
Risk-management file summary, hazard analysis, usability validation records, cleaning instructions, and residual-risk labeling. |
Risk controls should follow a documented process consistent with ISO 14971; user-facing controls should be clear and testable. |
Safety information depends only on operator experience, or the supplier cannot explain residual risks. |
| Clinical Function and Training Value |
10% |
Range of motion, resistance or assistance settings, measurement accuracy, patient positioning, data display, and suitability for rehabilitation protocols. |
Demonstration videos, functional test results, calibration records, clinical-use references, and an on-site or remote product demonstration. |
Functions should match the training center’s patient groups, therapist workflow, infection-control procedures, and available space. |
Marketing focuses on appearance or specifications without showing repeatable clinical operation. |
| Factory and Supplier Capability |
8% |
Production capacity, engineering resources, incoming inspection, final inspection, supplier control, and ability to maintain consistent batches. |
Factory audit, production-flow photographs or video, sample inspection plan, batch records, capacity statement, and quality-control organization chart. |
The quoted production site, quality system, and technical team should match the facility and personnel responsible for the order. |
No site access, heavy dependence on undisclosed subcontractors, or inability to provide batch-level inspection evidence. |
| Customization and Integration |
6% |
Availability of custom dimensions, accessories, software settings, language options, data interfaces, and room-layout adaptations. |
Confirmed specification sheet, change-control procedure, interface documentation, prototype approval process, and revised drawings. |
All custom requirements should be written into the approved quotation, drawings, purchase order, and acceptance criteria. |
Verbal promises, undocumented modifications, or changes that could invalidate existing test reports. |
| Installation and Commissioning |
6% |
Site preparation, delivery, assembly, calibration, operator onboarding, acceptance testing, and installation documentation. |
Installation method statement, site-readiness checklist, commissioning report template, training agenda, and acceptance-test protocol. |
The supplier should define responsibilities, required utilities, floor space, safety clearances, and acceptance criteria before shipment. |
Delivery is treated as complete without installation verification, calibration, or user training. |
| Technical Support and Response |
8% |
Support channels, engineer availability, troubleshooting process, spare-parts identification, remote diagnostics, and escalation procedures. |
Service-level agreement, support contacts, ticket workflow, troubleshooting guides, spare-parts catalog, and sample service report. |
A practical target is acknowledgment within one business day and a documented escalation route for safety-critical issues. |
Only sales contacts are available, support is limited to messaging apps, or technical questions are answered inconsistently. |
| Warranty and Spare Parts |
5% |
Warranty duration, exclusions, replacement procedure, consumables, preventive-maintenance parts, and expected parts availability. |
Written warranty policy, parts list, recommended maintenance schedule, replacement lead times, and repair responsibility matrix. |
A clearly defined warranty of at least 12 months is a practical purchasing benchmark, subject to contract terms and local law. |
Warranty excludes core components, parts have no identification codes, or replacement lead times are not stated. |
| Documentation and Language |
3% |
Completeness, accuracy, revision control, translation quality, warning labels, and consistency across manuals and certificates. |
Current user manual, service manual, spare-parts list, installation guide, labeling artwork, certificate copies, and document revision history. |
Documents should identify the exact model, revision, intended use, contraindications, maintenance requirements, and responsible legal entity. |
Copy-and-paste errors, contradictory specifications, missing warnings, or documents supplied only after payment. |
| Total Cost of Ownership |
4% |
Purchase price plus shipping, installation, training, calibration, software fees, consumables, maintenance, energy use, and replacement parts. |
Itemized quotation, Incoterms, payment schedule, annual maintenance estimate, spare-parts pricing, and five-year operating-cost projection. |
Compare suppliers using the same configuration, delivery terms, service scope, warranty period, and acceptance criteria. |
A low initial price hides installation fees, software charges, import costs, or unavailable replacement parts. |