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Quality Control
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Qualification to see Genial's strength

According to the requirements of GMP and ISO13485, Genial Technology has established a quality management system, and introduced a performance excellence evaluation management system to manage the company's daily operation, product research and development, production and manufacturing, quality control and other links, through supplier evaluation, incoming material inspection, process inspection, finished product inspection and other processes to control. To ensure the continuous production of products that meet the intended use and regulatory requirements, and improve the company's overall performance and ability to create value for customers and other stakeholders.

At present, Genial has passed ISO 13485 International Medical Device Quality Management system certification, ISO 45001 Occupational Health and Safety management system certification, ISO 14001 environmental management system certification, GB/T 29490 intellectual property management system certification, safety production standardization certificate,BSCI(Business Social Compliance Initiative). The products have passed CE, FDA, ROHS, NMPA, CB, FCC, REACH and other certifications, and the quality of Genial's products have been tested in 117 countries.

ISO13485

ISO13485

ISO45001

ISO45001

ISO14001

ISO14001

Intellectual property management system certification

Intellectual property management system certification

BSCI Social Responsibility System Certification

BSCI Social Responsibility System Certification

CE certification

CE certification

FDA-510K

FDA-510K

Electronic thermometers ROHS

Electronic thermometers ROHS

Electronic thermometers FCC

Electronic thermometers FCC

CB Certificate

CB Certificate

Professional Quality Inspection Equipment

Professional and perfect inspection equipment are the consistent guarantee of Genial product quality

Product Life Test

Product Life Test

To ensure that the digital thermometer,digital blood pressure monitor and other products can meet the design requirements of the button times

Thermometer Measurement Accuracy Test

Thermometer Measurement Accuracy Test

All digital thermometers are tested by constant temperature tank to ensure the accuracy of thermometers meets requirements

Voltage Resistance Safety Test

Voltage Resistance Safety Test

Intuitively, accurately, quickly and reliably test the breakdown voltage, leakage current and other electrical safety performance indicators of digital thermometers and digital blood pressure monitors

Digital Blood Pressure Monitor Accuracy Test

Digital Blood Pressure Monitor Accuracy Test

All the digital blood pressure monitors are tested by blood pressure simulation test to ensure that the accuracy of the blood pressure monitors meets the requirements

Using Environment tTesting

Using Environment tTesting

It simulates the influence of temperature and humidity on the performance of digital thermometers,digital blood pressure monitors and other products in different working and storage environments for a long time to ensure the safety and stability of product performance

Salt Spray Environment Test

Salt Spray Environment Test

The environmental test mainly uses artificial simulated salt fog environment conditions created by salt fog test equipment to examine the corrosion resistance of products or metal materials

Testing video

Genial has built its own product laboratory and testing system, and introduced many product testing equipment certified by domestic and foreign standards. Each product has gone through at least 13 testing processes

Obtain Domestic and Foreign Certification

Genial has won 206 honorary qualifications at home and abroad

Medical device manufacturing license
Registration form of medical device manufacturing products
Class A medical device manufacturer
FDA(510K)
ISO13485
ISO45001
ISO14001
BSCI(Business Social Compliance Initiative)
Digital Thermometer RoHS
Intellectual property management system certification

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