1 Requirement Definition | Translates the intended use into measurable product requirements, such as skin moisture, oil level, pigmentation, pore appearance, or surface imaging. | - Measurement parameters and operating range
- Target users and intended environment
- Required languages, connectivity, and reporting functions
| Regulatory status depends on the intended purpose and marketing claims. A cosmetic consultation tool may be treated differently from a device making diagnostic or treatment claims. | A clearer specification and fewer unsuitable product quotations. |
2 Technical Screening | Compares optical systems, sensors, image resolution, illumination, software functions, measurement repeatability, and user workflow across available models. | - Technical datasheet
- Operating and storage conditions
- Calibration or verification procedure
- Sample measurement reports
| Performance claims should be supported by documented test methods. “Accuracy” and “repeatability” should not be accepted without defined test conditions. | More objective product comparison and better technical due diligence. |
3 Quality-System Review | Helps verify whether the manufacturer has documented controls for design, production, supplier management, complaint handling, and corrective actions. | - Quality-management certificate, if applicable
- Factory audit or assessment records
- Incoming inspection and final-test procedures
- Warranty and service process
| ISO 13485 may be relevant when the product is a medical device. Certification alone does not prove that a specific product is approved in every destination market. | Lower supplier risk and improved consistency between sample and production units. |
4 Regulatory Classification | Coordinates an initial review of intended use, product claims, software functions, accessories, and destination-market requirements. | - Product intended-use statement
- Labeling and user manual
- Declaration of conformity, where applicable
- Regulatory registration or listing information, where required
| Classification is jurisdiction-specific. United States, European Union, United Kingdom, and other markets may apply different rules based on claims and risk. | Earlier identification of approval, registration, or labeling requirements. |
5 Safety and Risk Review | Collects available safety evidence for electrical, optical, mechanical, software, and usability risks and routes technical questions to the manufacturer. | - Risk-management summary
- Electrical-safety and electromagnetic-compatibility test reports, when applicable
- Optical safety information
- Cleaning and maintenance instructions
| ISO 14971 can apply to medical-device risk management. IEC 60601-1 and related standards may apply to medical electrical equipment, depending on classification and market. | Better control of safety gaps before import, installation, and customer use. |
6 Software and Data Protection | Reviews account permissions, cloud functions, image storage, software updates, data export, cybersecurity controls, and technical support responsibilities. | - Data-flow description
- Privacy policy and retention policy
- Software version and update method
- Backup, deletion, and access-control procedures
| Skin images and customer records may constitute personal data. Applicable privacy obligations can include consent, transparency, security, retention, and cross-border transfer controls. | Reduced privacy exposure and clearer ownership of customer data. |
7 Import Documentation | Helps align commercial, shipping, and product documents before dispatch and coordinates communication among the manufacturer, freight provider, customs broker, and importer. | - Commercial invoice
- Packing list
- Correct product description and tariff classification
- Country-of-origin information
- Applicable conformity documents
| Customs and import requirements vary by destination. The importer remains responsible for using accurate declarations and meeting local obligations. | Fewer customs delays, document discrepancies, and unexpected import issues. |
8 Sampling and Validation | Arranges samples, demonstrations, operator training, acceptance criteria, and comparison tests before a larger purchase. | - Signed sample evaluation checklist
- Measurement repeatability results
- Image-quality and report-format review
- Packaging and accessory inspection
| Validation should reflect the actual intended environment, users, skin conditions, lighting conditions, and software workflow. | Evidence-based purchasing decisions and reduced post-delivery disputes. |
9 Training and Market Launch | Provides installation guidance, operator training, translated materials, troubleshooting support, and procedures for handling customer complaints. | - Training records
- Localized user manual
- Service-level and response-time terms
- Spare-parts and repair process
| Product claims, instructions, and promotional materials should remain consistent with the approved or legally permitted intended use in each market. | Faster deployment, more consistent operation, and better customer support. |
10 Post-Market Support | Consolidates feedback, warranty cases, service requests, software issues, and field-performance information for communication with the manufacturer. | - Complaint and incident records
- Corrective-action documentation
- Repair and replacement history
- Software change records
| Medical-device markets may require formal vigilance, complaint handling, or corrective-action processes. Requirements depend on product classification and jurisdiction. | Improved lifecycle control and faster response to quality or compliance issues. |