| Quality management system |
Whether the manufacturer controls design, production, corrective actions, supplier qualification and traceability. |
ISO 13485:2016; applicable national regulatory requirements. |
Current certificate, issuing body, scope, manufacturing-site coverage and audit status. |
Confirm the certificate applies to the actual product category and production site; certification alone does not establish product approval. |
| Regulatory status by destination market |
Whether each device is lawfully placed on the market in the buyer’s intended country and for its intended use. |
EU Medical Device Regulation (EU) 2017/745 where applicable; U.S. FDA requirements where applicable; relevant local registration rules. |
Declaration of conformity or clearance/authorization records as applicable, device classification, intended-use statement and market-specific registration details. |
Verify status using the relevant regulator’s records. Requirements differ by jurisdiction, device type and risk class. |
| Electrical safety and essential performance |
Electrical shock, mechanical, thermal and essential-performance risks for powered medical equipment. |
IEC 60601-1, where applicable, plus the relevant particular standard for the device. |
Test reports from a competent laboratory, model and configuration covered, and current risk-management documentation. |
Check that reports cover the supplied configuration and intended operating environment, not merely a similar model. |
| Electromagnetic compatibility |
Whether equipment can operate as intended amid electromagnetic disturbances and does not create unacceptable interference. |
IEC 60601-1-2, where applicable. |
EMC test report identifying the device, tested accessories, test levels and pass criteria. |
Review suitability for the intended clinical setting, including use near other equipment or wireless systems. |
| Risk management |
Identification and control of hazards throughout the device life cycle, including risks related to intended users and patient populations. |
ISO 14971:2019, where applicable. |
Risk-management summary, hazard-control evidence, residual-risk evaluation and post-market monitoring process. |
Check that foreseeable misuse, cleaning, maintenance and paediatric use conditions are addressed where relevant. |
| Paediatric suitability |
Whether the device’s intended purpose, sizing, operating ranges, accessories and instructions support the stated paediatric population. |
Applicable device-specific standards and regulatory requirements; no single standard covers all paediatric equipment. |
Intended-use and age/size ranges, clinical or performance validation, compatible accessories, and instructions for use. |
Match specifications to the intended patients and care setting; do not assume adult-device validation establishes paediatric suitability. |
| Biological safety of patient-contacting materials |
Potential biological risks based on the nature and duration of contact with the patient. |
ISO 10993 series, applied according to contact type and duration where applicable. |
Biological evaluation documentation and relevant test results or rationale for the assessment. |
Confirm the assessment covers the supplied materials and finished device, including relevant accessories. |
| Labelling and instructions |
Clarity of intended use, warnings, setup, cleaning, maintenance, storage and safe-use instructions. |
ISO 20417 and ISO 15223-1, where applicable; destination-market rules. |
Current labels, symbols list, instructions for use and available language versions. |
Check that translations are complete and that local-language labelling meets the destination market’s requirements. |
| Service, maintenance and spare parts |
Availability of installation, preventive maintenance, repairs, calibration where needed, training and replacement parts. |
Manufacturer instructions and applicable local servicing and safety requirements. |
Service plan, warranty terms, parts list, technical support arrangements and training materials. |
Agree on response times, service responsibilities and parts availability before purchase; avoid relying on verbal assurances. |
| Supply-chain and delivery reliability |
Production capacity, lead-time transparency, packaging, shipment tracking and contingency planning. |
Contract terms, applicable transport and import rules, and product-specific storage requirements. |
Written delivery schedule, packaging specifications, shipping documents and escalation process. |
Evaluate delivery performance using documented order history and confirm any temperature, humidity or handling constraints. |
| Post-market support and vigilance |
Processes for complaints, incident reporting, corrective actions, recalls and safety notices. |
Applicable post-market surveillance and vigilance rules in each destination market. |
Complaint-handling procedure, contact details, recall process and examples of safety communications where available. |
Confirm how quickly the supplier informs buyers of safety issues and how affected units can be traced. |