| Legal Entity and Market Authorization | Confirm the distributor's registered legal entity, operating address, authorized signatory, tax registration, and right to sell medical or aesthetic equipment in the target market. | Current business registration, tax certificate, physical-office verification, signed authorization letter, and local market permits where required. | All legal documents are current and independently verifiable. | 10% | Unverifiable address, mismatched legal names, or refusal to provide registration documents. |
| Regulatory Classification | Establish whether the skin analyzer is a medical device, cosmetic-use device, wellness product, or general electrical equipment in the intended country. | Written classification rationale, intended-use statement, regulatory submission records, and market-specific compliance documents. | Classification is consistent with the product's claims, software functions, and intended users. | 12% | The distributor describes a medical device as “non-regulated” solely to avoid compliance obligations. |
| Product Conformity and Safety | Review electrical safety, electromagnetic compatibility, usability, risk management, and applicable product testing for the analyzer and accessories. | Applicable test reports, declaration of conformity, risk-management file summary, user manual, labeling samples, and maintenance instructions. | Documentation is complete, product-specific, current, and issued by competent assessment or testing bodies. | 12% | Generic certificates, incomplete reports, altered documents, or certificates covering a different model. |
| Quality Management System | Assess whether the manufacturer and distributor operate controlled processes for complaints, corrective actions, document control, training, and product traceability. | Valid ISO 13485 certificate where applicable, quality manual excerpts, complaint procedure, corrective-action records, and training records. | Documented quality processes with named responsible personnel and audit history. | 10% | No complaint process, no traceability, or quality certificates that cannot be validated with the issuing body. |
| Calibration and Measurement Reliability | Determine how the distributor controls camera calibration, lighting consistency, measurement repeatability, software updates, and environmental limitations. | Calibration procedure, acceptance criteria, repeatability or reproducibility data, service records, and controlled software-version history. | Calibration intervals and performance limits are documented and tested under defined conditions. | 12% | Claims of “AI accuracy” without a test protocol, sample size, reference method, or stated limitations. |
| Clinical or Technical Validation | Check whether diagnostic or skin-condition claims are supported by appropriate validation rather than only marketing images or testimonials. | Validation protocol, representative test population, reference standard, performance metrics, limitations, and version-controlled results. | Claims are limited to the validated intended use and supported by reproducible evidence. | 12% | Guaranteed diagnosis, treatment promises, or unsupported claims about detecting disease or skin conditions. |
| Data Protection and Cybersecurity | Review collection, storage, transfer, retention, access control, encryption, backup, deletion, breach response, and third-party cloud processing. | Privacy notice, data-flow diagram, processing agreement, security controls, user-permission matrix, vulnerability-management policy, and deletion procedure. | Personal and facial-image data are processed lawfully with documented security and retention controls. | 12% | Shared passwords, unrestricted cloud access, unclear data ownership, or no method to delete patient images. |
| After-Sales Service Capacity | Measure local capability for installation, training, troubleshooting, preventive maintenance, spare parts, firmware updates, and escalation to the manufacturer. | Named service engineers, training certificates, service-level agreement, spare-parts list, escalation matrix, and sample service reports. | Local first-line support with documented response and resolution targets. | 10% | All support is remote, no spare-parts plan, or dependence on one untrained technician. |
| Warranty and Total Cost of Ownership | Compare warranty duration, exclusions, shipping responsibility, consumables, software subscriptions, installation fees, calibration costs, and repair pricing. | Itemized quotation, warranty terms, service-rate card, subscription schedule, replacement policy, and five-year operating-cost estimate. | All recurring and non-recurring costs are disclosed before purchase. | 8% | Low purchase price followed by undisclosed software, calibration, data, or mandatory service charges. |
| Commercial References and Track Record | Verify experience with comparable installations, customer support performance, delivery history, and ability to serve the target geography. | At least three independently contacted customer references, anonymized service metrics, delivery records, and evidence of completed installations. | References confirm product availability, service quality, training, and complaint handling. | 7% | Only unverifiable testimonials, pressure to skip reference checks, or frequent changes in sales representatives. |
| Contract and Exit Protection | Ensure the contract addresses delivery acceptance, uptime, data ownership, confidentiality, software access, termination, refunds, and business continuity. | Reviewed distribution or purchase agreement, service-level agreement, data-processing terms, warranty schedule, and exit or migration plan. | The buyer retains access to its data and can exit without losing essential records or support. | 5% | Verbal promises, unilateral price changes, locked data, or no remedy for prolonged downtime. |