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Precision Medical Instruments Parts Manufacturers

Product application medical equipment display backplane, base, applicable to a variety of medical equipment

Suzhou Heaten Machinery Industry Co.,Ltd.

About Us

Suzhou Heaten Machinery Industry Co., Ltd.

Founded in 2012, Suzhou Heaten is a professional metal mold design & fabrication supplier and precision part manufacturer. Heaten’s products are widely used in automotive, consumer electronics, medical and others. We focus on deep drawing, precision metal mold design and product manufacturing.

Suzhou Heaten Machinery Industry Co.,Ltd. is China Custom Precision Medical Instruments Parts Manufacturers and OEM/ODM Precision Medical Instruments Parts Company. We have rich experience in stainless steel, aluminum, copper, iron and other materials. Our equipment includes: 30 sets of stamping precision processing equipment (110T-1000T punch press), 20 sets of mold manufacturing equipment (wire cutting machine, processing center, water mill, precision grinding, etc.) and inspection and testing equipment (hexcon coordinate, 2.5 dimensional, salt spray testing machine, etc.).

We are certified by IATF16949, ISO9001 and ISO14001. We carry out "Service, Quality" concept and people-oriented principle to meet the needs of customers.

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When Suzhou Heaten Machinery Industry Co., Ltd. produces Precision Medical Instruments Parts, what quality control processes does it have to ensure that the products meet international certification standards?

1. Quality control of raw materials
When producing precision medical instrument parts, the selection of raw materials is crucial. Suzhou Heaten Machinery Industry Co., Ltd.'s quality control process for raw materials includes the following aspects:

Supplier selection and review
Suzhou Heaten Machinery Industry Co., Ltd. will strictly screen suppliers to ensure that all materials come from certified and reliable suppliers. All potential suppliers will be reviewed in detail to evaluate their production capacity, quality control system, product quality and delivery time to ensure the stability and consistency of materials.

Material incoming inspection
All raw materials arriving at the factory need to be strictly inspected before entering the production process. The company is equipped with special testing equipment, such as X-ray fluorescence analyzers, spectrometers, etc., to detect the chemical composition, physical properties and surface quality of materials. Ensure that each batch of materials meets the design requirements, especially the performance standards such as corrosion resistance, oxidation resistance, and high temperature resistance required for medical devices.

Material certificate and certification traceability
All purchased materials must provide a certificate of conformity and have the corresponding international standard certification (such as ISO, ASTM, etc.). The company conducts traceability management on each batch of raw materials to ensure that the specific supplier and material batch can be traced back to the production process to ensure quality control.

2. Quality control in the production process
When producing precision medical device parts, the company will strictly operate in accordance with the quality management system of ISO9001 and IATF16949 to ensure quality control in every link of the production process. The company's quality control process includes:

Use and calibration of precision equipment
The company has a number of high-precision stamping equipment (110T-1000T punching machine), mold manufacturing equipment (wire cutting machine, machining center, water mill, precision grinder, etc.) and inspection equipment (hexagonal coordinate measuring machine, 2.5-dimensional, salt spray tester, etc.). All equipment has undergone strict installation and commissioning, and regular calibration to ensure that its accuracy meets production requirements. In addition, the operators of the equipment must undergo professional training to ensure that the equipment can operate stably and achieve the expected production accuracy.

Process quality control
During the production process, the company strictly controls the process requirements of each link, including stamping, precision machining, welding, surface treatment, etc. Each process link will be monitored in real time, and the data will be recorded through the automation system to form a production file. For key processes, the company will set up special quality inspection points to ensure error-free transmission between processes. After each production stage is completed, the size, appearance, performance and other aspects will be tested to ensure that each component meets the design requirements.

Maintenance of molds and equipment
As a key tool for producing precision parts, the company regularly inspects and maintains the molds. Each mold will be inspected for size and surface quality before and after use to avoid quality problems caused by mold wear or damage. At the same time, the company will continuously optimize the mold design according to production needs to improve production efficiency and product accuracy.

3. Quality inspection and testing of final products
After all production processes are completed, the company will conduct comprehensive quality inspection and testing on precision medical device parts to ensure that each product meets international certification standards. Quality control at this stage includes:

Dimension and appearance inspection
Use precision testing equipment such as coordinate measuring machines (CMM) to measure the size of parts. For parts with complex shapes, the company uses high-precision 2.5-dimensional testing equipment to ensure that each dimension of the parts is within the tolerance range. In terms of appearance inspection, strictly check whether there are defects on the surface of the parts, such as scratches, pores, etc.

Functional testing
Precision medical device parts must not only meet the size requirements, but also ensure their functionality. The company will conduct various functional tests according to the design requirements of the product, including but not limited to corrosion resistance tests, high temperature resistance tests, fatigue resistance tests, etc. In particular, for parts used in medical environments, the company will conduct strict biocompatibility tests to ensure the safety and harmlessness of the products.

Reliability testing
The company is equipped with high-standard testing equipment such as salt spray testers to conduct long-term corrosion resistance tests to simulate the use of parts in extreme environments. Through accelerated aging tests, the stability and reliability of parts during long-term use are evaluated to ensure that they meet the high standards of the medical device industry.

Reporting and traceability
All test results will form a formal quality report and be associated with the production batch to ensure that each product shipped has a complete quality traceability record. If any product that does not meet the requirements is found, it will be immediately repaired or scrapped, and unqualified products will never be allowed to enter the market.

IV. International Certification and Quality Management System
The company has passed international quality management system certifications such as IATF16949, ISO9001 and ISO14001, which means that the company not only implements strict quality control in the production process, but also follows the world's leading quality management concept to ensure the traceability and sustainability of products.

IATF16949
As the quality management standard of the automotive industry, IATF16949 requires suppliers to provide high-precision and reliable products. The company strictly abides by this standard to ensure that its precision medical device parts can meet high standards of quality requirements.

ISO9001
As an internationally accepted quality management system standard, ISO9001 ensures that the company has strict quality control and continuous improvement mechanisms in the production process. The company conducts internal audits regularly to ensure that the quality control of each department meets the standard requirements.

ISO14001
In terms of environmental management, the company has passed ISO14001 certification to ensure that the environmental impact of the production process is effectively controlled and meets environmental protection requirements.