| Quality Management System |
ISO 9001:2015; ISO 13485:2016 where the products are medical devices or are manufactured under a medical-device quality system. |
Confirm certificate scope, issuing certification body, validity dates, covered manufacturing sites, and product categories. |
15% |
Current certificate, audit report summary, documented corrective-action process, and site address matching the quotation. |
Inconsistent production quality, weak traceability, and delayed corrective actions. |
| Regulatory Classification |
Applicable rules depend on destination market, intended use, risk class, and whether the equipment is a medical device, laboratory product, or general-use item. |
Check that the supplier has identified the correct product classification and market-specific obligations before delivery. |
15% |
Regulatory classification rationale, declaration of conformity where applicable, registration details, and technical documentation index. |
Import delays, unlawful distribution, recalls, or inability to use the equipment clinically. |
| Electrical Safety |
IEC 60601-1: Medical electrical equipment—general requirements for basic safety and essential performance, when applicable. |
Verify applicable test reports, electrical ratings, protective-earth requirements, leakage-current results, and essential-performance criteria. |
12% |
Test report from a competent laboratory, product label photographs, user manual, and installation requirements. |
Electric shock, fire, electromagnetic interference, or unsafe operation in a clinical environment. |
| Risk Management |
ISO 14971:2019 for risk-management processes for medical devices. |
Ask whether hazards, foreseeable misuse, residual risks, and risk controls are documented throughout the product life cycle. |
10% |
Risk-management summary, hazard analysis, residual-risk information, and evidence that warnings match the user manual. |
Uncontrolled hazards, inadequate warnings, and avoidable injury to animals or staff. |
| Radiation and Imaging Safety |
IEC 60601-1-3 for diagnostic X-ray equipment and applicable particular standards such as IEC 60601-2-54 for radiography and radioscopy equipment. |
Confirm shielding, dose-control features, image-quality testing, warning indicators, servicing procedures, and local radiation requirements. |
10% |
Radiation-safety test records, installation plan, acceptance-test procedure, calibration records, and operator training materials. |
Unnecessary exposure, non-compliance with local rules, poor diagnostic quality, or equipment downtime. |
| Biocompatibility and Materials |
ISO 10993 series where equipment or accessories have direct or indirect patient contact. |
Identify contact type and duration, cleaning chemicals, sterilization method, latex content, and material compatibility. |
8% |
Material declarations, biocompatibility assessment, cleaning validation, sterilization instructions, and safety data sheets where relevant. |
Skin or tissue reactions, premature material failure, contamination, or invalid cleaning procedures. |
| Cybersecurity and Software |
IEC 81001-5-1 may apply to health-software cybersecurity; connected equipment should also have documented secure-update and vulnerability processes. |
Review access control, encryption, audit logs, network requirements, vulnerability disclosure, backup, and end-of-support policy. |
8% |
Cybersecurity file, software bill of materials where available, update policy, penetration-test summary, and incident-response contact. |
Data loss, unauthorized access, ransomware exposure, or interruption of clinical services. |
| Calibration and Metrology |
Calibration should be traceable to recognized national or international measurement standards, with intervals based on risk and use. |
Check calibration tolerances, due dates, reference standards, adjustment records, and procedures for out-of-tolerance results. |
8% |
Calibration certificate, traceability statement, preventive-maintenance schedule, and service history. |
Incorrect measurements, missed diagnoses, invalid test results, and audit findings. |
| Installation and Training |
Installation, operating, cleaning, maintenance, and training instructions must match the supplied configuration and intended users. |
Confirm commissioning tests, competency assessment, language availability, and training for veterinarians, technicians, and maintenance staff. |
7% |
Signed installation checklist, training records, user manual, service manual access, and competency certificates. |
User error, equipment damage, preventable downtime, and unsafe maintenance. |
| Service and Spare-Parts Support |
Support commitments should cover preventive maintenance, corrective repair, spare-parts availability, and safety-related field actions. |
Compare response time, local technician competence, parts lead time, warranty exclusions, and escalation procedures. |
7% |
Service-level agreement, warranty terms, service network details, parts list, and documented recall or field-safety-notice process. |
Long outages, unsafe repairs, unexpected ownership costs, and unavailable replacement parts. |