| Quality management system | ISO 13485 — Quality management systems for medical devices | Current certificate; certification body and accreditation details; certificate scope, site address, and covered activities; audit findings and corrective-action records. | Checks whether documented controls cover areas such as design, production, traceability, supplier management, complaints, and corrective actions. Verify that the certified site and scope match the work being purchased. |
| Risk management | ISO 14971 — Application of risk management to medical devices | Device-specific risk-management summary; hazard analysis; risk-control measures; residual-risk evaluation; evidence that production and post-market information feed back into risk reviews. | Shows whether hazards such as electrical shock, burns, excessive output, incorrect settings, and foreseeable misuse are identified and controlled throughout the device life cycle. |
| Electrical safety and essential performance | IEC 60601-1 — Medical electrical equipment: general requirements for basic safety and essential performance | Test report or certificate for the exact model and configuration; laboratory identity and accreditation scope; critical-component list; production inspection and electrical-safety test records. | Provides evidence that the equipment has been evaluated for relevant medical electrical safety and essential-performance requirements. Check that accessories, power supplies, and configurations are covered where applicable. |
| Electromagnetic compatibility | IEC 60601-1-2 — Electromagnetic disturbances: requirements and tests | EMC test report identifying the model, tested cables and accessories, operating modes, test levels, and pass/fail results; change-control records for components that can affect EMC. | Assesses whether electromagnetic emissions and immunity have been evaluated for the intended use environment. A report for a different model or materially different configuration may not be sufficient. |
| Therapeutic electrical stimulators | IEC 60601-2-10 — Particular requirements for the basic safety and essential performance of nerve and muscle stimulators, where applicable | Product classification and intended-use statement; applicable test reports; output-characteristic test results; verification of controls, leads, electrodes, and protective features. | Provides device-specific assessment for equipment within the standard’s scope, such as applicable nerve or muscle stimulators. Confirm applicability rather than assuming it covers every physiotherapy device. |
| Software and programmable functions | IEC 62304 — Medical device software life-cycle processes, where software is part of the device | Software life-cycle documentation; software version and configuration records; verification and validation summaries; anomaly and change-management records; cybersecurity documentation where relevant. | Helps determine whether software development, testing, maintenance, and changes are controlled. Applicability depends on the device’s software and regulatory classification. |
| Usability and use-related safety | IEC 62366-1 — Application of usability engineering to medical devices | Usability-engineering file or summary; intended-user and use-environment definitions; use-related risk analysis; validation evidence for safety-relevant tasks and controls. | Checks whether foreseeable use errors have been considered, including selection of treatment settings, attachment of accessories, and interpretation of warnings and instructions. |
| Patient-contacting materials | ISO 10993 series — Biological evaluation of medical devices, where patient contact applies | Material and contact-duration information; biological evaluation plan and report; relevant test reports or scientific rationale; supplier and material-change controls. | Assesses whether biological risks have been evaluated for the actual patient-contacting parts, such as electrodes or applicators. The required evaluation depends on the nature and duration of contact. |
| China market authorization | Applicable National Medical Products Administration (NMPA) registration or filing requirements | Registration certificate or filing information, as applicable; product name, model, intended use, manufacturer, and approved technical information; check the details against the product offered. | Helps verify that the device has the required China-market authorization for its classification and that the offered model and intended use align with the regulatory documents. |
| Manufacturing authorization and traceability | Applicable Chinese medical-device production requirements; requirements depend on device class and the manufacturer’s role | Relevant production license or filing records, where required; manufacturing-site details; batch or serial-number traceability; inspection records; complaint, recall, and corrective-action procedures. | Helps confirm that the responsible manufacturing site and production controls are identifiable. Check which authorizations apply to the product class and whether the supplier is the manufacturer or an intermediary. |
| Supplier and production controls | ISO 13485 supplier-control provisions and the manufacturer’s documented purchasing and production procedures | Approved-supplier controls; incoming-inspection criteria; process-validation records where needed; calibration records; nonconformance and corrective-action samples; change-notification terms. | Shows how the organization controls components and processes that can affect safety and performance, and whether changes are reviewed before they reach supplied products. |
| Document consistency | Applicable standards, regulatory documents, labeling, and technical documentation for the device and destination market | Compare model numbers, manufacturer and site details, intended use, test samples, certificate scope, labels, instructions for use, and accessories across the submitted documents. | Inconsistencies can indicate that evidence does not cover the product being offered. Verify document validity with the issuing body or regulator when practical. |
