INNOP specializes in the production of medical endoscope camera system, medical cold light source and other medical equipment. Our manufacturing base is aimed to inspect materials, store materials, assembling products, carry out quality test and the boxing of finished products as well as the delivery of the products.
The testing equipment we adopt includes: 3G-SDI oscilloscope, medical leakage current tester, medical grounding resistance tester, medical withstand voltage tester, medical high-frequency electric knife interference simulator, smart spectrum analyzer and color matching cabinet.
Our products have been certified with CE, ISO13485 and ISO 9001 certification.
INNOP has established several testing processes to ensure the products are made with excellent quality. The processes include:
IQC, or incoming quality control, which inspects materials in accordance with the design specifications, blueprints, materials, and samples of finished products.
IPQC, or inn process quality control, which inspects every finished product. During the inspection, the product’s materials, software, appearance and functions will be closely examined. After the product passes all the tests, mass production will be carried out. After that, the appearance of the products will be examined again and digital oscilloscope will be used to conduct performance test.
Stress test, which involves stress test chambers to test the quality and durability of the products. After passing the 72-hour aging test, the products are qualified for the next test. The whole test is conducted based on the environmental and mechanical requirements of GB/T14710.
QA test, or quality assurance test, which tests the quality and durability of medical endoscope camera and medical LED cold light source. The test focuses on grounding resistance, leakage current, withstand voltage, noise test, surface temperature test and transportation simulation. In addition, the parameter of medical cold light source will be tested by spectrum analyzer.
OQC, or outgoing quality test, which is responsible for testing products before they are boxed. Medical endoscope camera system, medical LED cold light source, medical display, endoscope coupler and laparoscope will be put together. Then, physical buttons will be tested. And after the parameters have all been set, special colour cards will be applied to ensure the images will not be distorted. After that, the finished products will be cut by high-frequency electric knife and will undergo electro-coagulation test. When their image color, clarity, and anti-interference performance are qualified, the products’ appearance will be inspected. Finally, label will be pinned and after relevant information is prepared, the products will be wrapped up.
All our products have their own symbols, and are included in DHR files for traceability. Production, quality control, and after-sales are conducted in accordance with ISO9001 and ISO13485. Quality management personnel and production management personnel have been trained by professional institutions and have obtained the qualification certificates of "Medical Device GMP Junior Commissioner" and "ISO9001 Internal Auditor".