Quality Management & Product Documentation

Quality &
Compliance

Review our inspection approach and production-support equipment. Request the quality information and compliance documents that apply to your model and destination market.

Company Quality Management

Company-Level
Quality Management

Company quality management and product-specific documents serve different parts of your manufacturing-partner assessment. Review both before confirming the order requirements.

Quality management documentation ISO 13485

Request the company quality management documentation, its named holder and applicable scope for your procurement review.

  • Company and manufacturing scope
  • Current document details
  • Inspection requirements for the product model
Production Quality Control

Multi-Stage
Inspection Process

Quality review covers incoming components, assembly checks, functions, power-on checks, appearance and packing. Inspection points and acceptance criteria are defined for the model and order.

Incoming Materials & Assembly

Steps 01–03
Incoming material inspection workstation
Step 01

Incoming Material Inspection

Review incoming materials and purchased components before they enter production.

Check Focus
Model/specification match, incoming condition and relevant component information.
Inspection Details
Inspection Basis
The component requirements and applicable incoming acceptance criteria.
Procurement Review
Confirm the incoming inspection points relevant to your model.
PCB assembly and soldering station
Step 02

Mainboard & Connection Checks

Review the assembled board and its connections before the next production stage.

Check Focus
Component placement, connections and applicable board-level functions.
Inspection Details
Inspection Basis
The model configuration, assembly requirements and relevant test points.
Procurement Review
Confirm which board-level checks apply to your device.
Component assembly line
Step 03

Assembly Checks

Review the device build before the machine is completed.

Check Focus
Mechanical fitting, wiring, connections and configuration.
Inspection Details
Inspection Basis
The model-specific build specification and approved configuration.
Procurement Review
Confirm the assembly features important to your order.

Functional & Complete-Machine Checks

Steps 04–06
In-process component checks
Step 04

Semi-Finished Functional Testing

Check core functions while the product is still in assembly.

Check Focus
Core operating functions and the settings relevant to the model.
Inspection Details
Inspection Basis
The applicable functional test points for the semi-finished unit.
Procurement Review
Agree the functional checks needed before full assembly.
Aging and power-on test rack
Step 05

Aging & Power-On Testing

Review assembled equipment during applicable power-on and aging checks.

Check Focus
Operation during the model-specific power-on and aging process.
Inspection Details
Inspection Basis
Duration, conditions and acceptance criteria are confirmed for the model.
Procurement Review
Request the applicable aging-test scope; do not assume one duration for all devices.
Complete device assembly station
Step 06

Complete Machine Inspection

Review the finished device against its configuration and functions.

Check Focus
Applicable functions, settings, interfaces and product configuration.
Inspection Details
Inspection Basis
The product specifications and agreed inspection requirements.
Procurement Review
Confirm the finished-device checks required for your purchase.

Appearance, Packing & Pre-Shipment Review

Steps 07–08
Finished-product appearance inspection
Step 07

Appearance & Branding Inspection

Review the finish and customer-facing details before packing.

Check Focus
Appearance, colors, branding, labels and visible assembly condition.
Inspection Details
Inspection Basis
The approved artwork and agreed appearance requirements.
Procurement Review
Provide branding artwork and appearance requirements before production.
Pre-shipment quality control workstation
Step 08

Packaging & Pre-Shipment Review

Products are inspected before shipment. The agreed scope determines which checks are performed.

Check Focus
Finished equipment, accessories, manuals, package contents and labels.
Inspection Details
Inspection Basis
The confirmed order configuration, packing requirements and applicable inspection points.
Procurement Review
Confirm the inspection scope and which items are checked per unit or per batch.
Pre-shipment QC image; third-party inspection photo pending

Illustrative pre-shipment QC photo; third-party inspection photo to be added.

On Request

Third-Party Inspection Support

Customer-arranged independent inspection can be coordinated with the production schedule.

Check Focus
The inspection agency’s requested scope and access needs.
Inspection Details
Inspection Basis
An inspection plan agreed for the model and order.
Procurement Review
Arrange the agency, scope and timing with our team in advance.
Equipment Behind the Process

Production & Quality
Support Equipment

The equipment supports different activities: environmental testing, component protection, processing, assembly and packing. The inspection scope is set for the product model.

Environmental Testing & Component Protection

Testing & storage
Programmable Temperature and Humidity Chamber
Environmental Testing

Programmable Temperature & Humidity Chamber

Conditions and test scope are confirmed for the product model.

Electronic Moisture-Proof Cabinet
Component Protection

Electronic Moisture-Proof Cabinet

Storage-support equipment; not an environmental test chamber.

Production & Assembly Equipment

Processing & assembly
Laser Machine
Production Equipment

Laser Machine

Laser equipment shown in the manufacturing setup.

Automatic Dispensing Machine
Production Equipment

Automatic Dispensing Machine

Dispensing equipment for production operations.

Film Coating Dispensing Machine
Production Equipment

Film Coating Dispensing Machine

Coating and dispensing process equipment.

Soldering Station
Assembly Equipment

Soldering Station

Soldering equipment used in assembly work.

Heat Gun
Assembly Support

Heat Gun

Heat-tool equipment supporting assembly operations.

Grinding Machine
Processing Equipment

Grinding Machine

Processing equipment in the manufacturing setup.

Bench Drilling Machine
Processing Equipment

Bench Drilling Machine

Drilling equipment supporting production work.

Cleaning Machine
Process Support

Cleaning Machine

Cleaning equipment supporting manufacturing operations.

Packing & Handling Equipment

Packing & handling
Automatic Packaging Machine
Packaging Equipment

Automatic Packaging Machine

Equipment supporting product packing.

Lifting Platform
Handling Support

Lifting Platform

Platform equipment supporting handling and assembly work.

Compliance & Certificates

Certificates &
Product Documentation

Lumivmed supports customers with compliance and regulatory documentation for their target markets. The availability and scope of applicable documents depend on the specific product model and destination market.

Lumivmed certificate and documentation overview
Certificate & documentation overview. Confirm the document holder, model, scope and current validity when requesting the corresponding files.

Applicable Documents May Include

  • CE / CE-MDR Documentation

    Confirm the documents available for the exact model and target market.

  • RoHS

    Request the available model-related documentation and its coverage.

  • FCC

    Confirm whether applicable documentation is available for your specific model.

  • Safety Test Reports

    Request available reports and check the covered model, scope and document details.

  • Certificate of Free Sale (CFS)

    Confirm availability and applicability for the model and destination market.

  • Authorization Documents

    Discuss the manufacturer or distributor authorization documents needed for your project.

  • FDA 510(k) Documentation

    For applicable models, request FDA 510(k) documentation and confirm the exact model and named document holder.

Procurement Review

Agree the Inspection
Scope for Your Order.

Provide the model, configuration, inspection priorities and target market. Ask which inspection information and records can be provided for the order before your procurement review.

  • Model and order configuration
  • Inspection points and acceptance criteria
  • Available inspection information and records
  • Required documents for the target market
Quality Feedback

Quality Feedback &
Technical Review

If an issue is reported, provide the model, order reference, a clear description and relevant photos. Our technical team can review the information and discuss the next steps.

Have Questions About Documentation or Quality Requirements?

Send the model, intended use, destination market and requested inspection or document requirements. Our team will review availability and the applicable scope for your order.

No. 8, Lane 25, Longye Industrial Zone, Dongguan City, Guangdong Province, China