| RF Technology | Confirm the operating frequency, output mode, electrode configuration, energy-control method, and intended treatment depth. | Technical specification, circuit description, user manual, and independent laboratory test data. | The same model number and configuration appear consistently on all technical documents. | Only marketing terms such as “deep RF” or “medical frequency” are provided without measurable specifications. |
| Output Accuracy | Check whether delivered RF power, pulse duration, temperature, and treatment time are monitored and controlled. | Calibration records, electrical safety test reports, and functional performance test procedures. | Test results identify the test method, equipment, date, model, serial number, and acceptance limits. | Unclear tolerances, missing test conditions, or identical test reports used for different models. |
| Temperature Control | Verify real-time skin or handpiece temperature sensing, automatic power reduction, and over-temperature shutdown. | Risk-management file, alarm verification, software validation, and temperature sensor calibration records. | The supplier demonstrates normal operation, sensor-fault handling, and automatic shutdown during a live video or witnessed test. | Temperature is displayed but not used for closed-loop control, or safety alarms can be disabled without authorization. |
| Electrical Safety | Assess protection against electric shock, leakage current, abnormal operation, fire, and mechanical hazards. | IEC 60601-1 may be relevant when the equipment is within its scope and is marketed as medical electrical equipment; confirm applicability with the conformity assessor. | A valid test report from a competent laboratory covering the exact model and rated configuration. | A generic CE logo, incomplete report, or a report for a visually similar but different product. |
| Electromagnetic Compatibility | Confirm that the machine does not create unacceptable interference and can tolerate expected electromagnetic disturbances. | IEC 60601-1-2 may apply to medical electrical equipment within its scope; other markets may require different EMC requirements. | EMC report lists emissions, immunity tests, test levels, operating modes, and the exact product identification. | Only an FCC or CE declaration is supplied without the underlying EMC test report. |
| Intended Use and Classification | Match the stated purpose, claims, user type, and treatment indications with the regulations of the destination market. | Applicable national or regional medical-device, cosmetic-device, electrical-safety, and consumer-product rules. | A written regulatory assessment that explains the product category and required market authorization. | The supplier says one certificate automatically covers every country or every intended use. |
| Quality Management System | Determine whether design, purchasing, production, inspection, complaints, and corrective actions are controlled. | ISO 13485 is relevant to quality-management systems for medical devices when applicable to the supplier’s products and market. | Certificate issued by a recognized certification body, showing the legal manufacturer, site address, scope, and validity. | Certificate belongs to another legal entity, covers a different site, has an expired validity period, or has an unrelated scope. |
| Risk Management | Review foreseeable risks such as burns, pain, unintended stimulation, electrical shock, infection, and misuse. | ISO 14971 provides a recognized framework for medical-device risk management when applicable. | Risk analysis links each significant hazard to design controls, warnings, verification tests, and residual-risk information. | A simple checklist is provided without hazard analysis, control verification, or residual-risk evaluation. |
| Software and Firmware | Check access control, software version identification, update procedures, error handling, and protection against unsafe settings. | Software validation records, change-control records, cybersecurity assessment, and user-access documentation. | The supplier can provide version history, validation evidence, backup procedures, and a documented update process. | Unrestricted service-menu access, undocumented firmware changes, or no recovery procedure after failed updates. |
| Product Certification | Verify that each declaration, certificate, and test report applies to the exact model, power supply, accessories, and market. | Market-specific declaration of conformity, electrical safety report, EMC report, and applicable regulatory registration or listing. | Documents contain traceable model numbers, legal manufacturer details, standards editions, dates, signatures, and issuing-body information. | “CE certified” is presented as a standalone badge without a declaration, technical file reference, or applicable standards. |
| Biocompatibility and Materials | Identify materials that contact the skin, including electrodes, gels, covers, handpieces, and reusable accessories. | ISO 10993 series may be relevant for materials with patient or user contact, depending on contact type and duration. | Material specifications, supplier declarations, cleaning compatibility, and applicable biocompatibility evaluation. | Unknown contact materials, unapproved substitutions, or no cleaning and replacement instructions. |
| Manufacturing Traceability | Verify incoming inspection, serial-number control, final testing, and traceability of critical components. | Quality records, batch or serial-number procedure, final inspection checklist, and component-control records. | A sample device can be traced from production records to final test results and shipment documentation. | No serial number, handwritten records without review, or inability to identify component revisions. |
| User Training and Instructions | Review contraindications, treatment parameters, preparation, cleaning, maintenance, emergency procedures, and operator qualifications. | Controlled user manual, training records, labeling review, and destination-market language requirements. | Manual content matches the delivered software and accessories and clearly explains safe operating limits. | Instructions omit contraindications, use vague treatment settings, or are unavailable in the required local language. |
| After-Sales Support | Evaluate spare-parts availability, response times, repair procedures, warranty terms, and corrective-action support. | Written warranty, service-level agreement, spare-parts list, maintenance schedule, and complaint-handling procedure. | Support obligations are defined by model, region, response time, covered parts, labor, and escalation process. | Warranty excludes critical parts, service is limited to messaging apps, or no formal recall and complaint process exists. |
| Pre-Shipment Inspection | Confirm that the delivered unit matches the approved sample and documented performance requirements. | Approved sample, purchase specification, acceptance test protocol, inspection report, and photographic records. | Independent or witnessed inspection verifies appearance, accessories, output, alarms, labels, packaging, and documentation. | Supplier refuses sample approval, third-party inspection, or testing against written acceptance criteria. |