World-Class Quality & Global Compliance

Driven by our "Quality First" philosophy, LEFIS manufactures premium medical aesthetic devices backed by rigorous quality control systems and prestigious international certifications. Discover our unwavering commitment to global safety standards, continuous innovation, and sustainable manufacturing.

Global Certifications

To ensure the highest level of safety and efficacy, LEFIS strictly adheres to global medical device standards. Our rigorous quality management system is backed by prestigious international certifications.

We maintain strict quality control in compliance with the ISO13485 system. Our products are certified by FDA, CE, and RoHS, and hold multiple design patents.Earning these authoritative credentials signifies that our products meet the most stringent global safety protocols, guaranteeing they can be legally distributed, sold, and confidently operated in diverse countries and regions worldwide.

Quality Control System

LEFIS is guided by a core quality policy: "Quality First, Integrity, Optimized Management, Continuous Innovation, Brand Building, and Customer Satisfaction." To consistently meet market demands and strict regulatory standards, we integrate these principles across our entire product lifecycle—spanning design, procurement, production, sales, and after-sales support.
Through this comprehensive approach, we have implemented the following key measures to achieve and maintain world-class quality standards:

Quality inspection process

In order to ensure that companies can continue to provide products and related services that meet customer requirements and applicable laws and regulations, the company has established a quality management system and adopted PDCA management methods.

Quality inspection process

Sales

We set up a PDCA team to collect data regularly to summarize and analyze the data,formula plans and solutions for problems which need to be solved.We will use quality management methods to inspect,analyze,improve and control our quality so that we can enhance the quality of our products.

Design

According to market development and customers requiremengts,our peofessional R&D engineers department will design documents of OEM peojects and newest technologies,including design pictures,internal structure,testing plans,verification confirmation process and conclusions to ensure that the devices super quality.

Preparation

We have professional process personnel and full-time IQC who will confirm the process and materials before sales to ensure that the quality of each machine sent out is perfect.

Manufacture

We have professional process personnel and full-time IQC who will confirm the process and materials before sales to ensure that the quality of each machine sent out is perfect.According to the production process,we have set up key control points, including self-inspection of production personnel and full-time OQC process inspection,so as to fundamentally control production quality.Before sales,a full-time PQC will conduct a comprehensive inspection of the products to strictly control the quality of each machine.

Sales

We set up a PDCA team to collect data regularly to summarize and analyze the data,formula plans and solutions for problems which need to be solved.We will use quality management methods to inspect,analyze,improve and control our quality so that we can enhance the quality of our products.

Design

According to market development and customers requiremengts,our peofessional R&D engineers department will design documents of OEM peojects and newest technologies,including design pictures,internal structure,testing plans,verification confirmation process and conclusions to ensure that the devices super quality.

Preparation

We have professional process personnel and full-time IQC who will confirm the process and materials before sales to ensure that the quality of each machine sent out is perfect.

Manufacture

We have professional process personnel and full-time IQC who will confirm the process and materials before sales to ensure that the quality of each machine sent out is perfect.According to the production process,we have set up key control points, including self-inspection of production personnel and full-time OQC process inspection,so as to fundamentally control production quality.Before sales,a full-time PQC will conduct a comprehensive inspection of the products to strictly control the quality of each machine.

Equipment Quality Assurance

LEFIS equipped with a variety of monitoring and measuring equipment, witch has been verified by the National Institute of Metrology, China to ensure product quality.

Equipment Quality Assurance

Withstand voltage and ground impedance tester

Detect the dielectric strength and impedance value of the product to ensure the electrical safety of the product.

Leakage current tester

Detect the leakage current of the product to the ground, the outer casing and the patient to ensure the safety of the product.

Oscilloscope

Monitor and measure multiple performance indicators of the process and finished products to ensure that the product meets the requirements of the standard.

Compliance & Sustainability

Over Other Synthetic Winch Ropes

At LEFIS, we are committed to the highest standards of regulatory compliance, ensuring our medical aesthetic devices meet the rigorous requirements of European and American medical device regulations. Our manufacturing excellence is rooted in strict adherence to ISO 13485 and ROHS standards, guaranteeing that every product is safe, reliable, and legally compliant for sale in diverse markets worldwide.
Beyond safety, we prioritize environmental stewardship as a core pillar of our sustainability strategy. We actively incorporate eco-friendly materials throughout our product development and have implemented green management practices to enhance production efficiency. By continuously optimizing our supply chain and focusing on waste reduction, LEFIS strives to minimize our environmental footprint while delivering high-performance technology to the global beauty industry.