Suzhou Menhow today proudly announces that its medical device manufacturing system has successfully passed the surveillance audit for the ISO13485:2016 standard by NQA (National Quality Assurance Ltd., UK) on November. This is of great significance for the quality control of our company's medical electrode products and medical-grade silicone rubber products. It ensures that every step, from the design to Printed Circuit and silicone rubber products, adheres to international quality standards, providing a solid guarantee for the safety and effectiveness of medical products.

Suzhou Menhow has a meticulous Design Validation (DQ) process. Firstly, it conducts a strict analysis of User Requirement Specifications (URS). When designing Printed ECG Electrode, engineers accurately translate the need for high - speed signal transmission and miniaturization into design blueprints. For custom rubber seals used in medical equipment, they ensure the products meet the requirements of biocompatibility and sealing performance.​

Secondly, the company adopts Failure Mode and Effects Analysis (FMEA) tools. In the design of Rubber Seals, potential risks such as material aging and dimensional changes are identified and eliminated, reducing the defect rate of new products to less than 0.3%.​ Moreover, an interdisciplinary collaboration platform is established. Materials engineers for silicone materials, and process engineers work together. They collaborate from the initial concept of a new medical device to the production of prototypes, ensuring seamless integration of functionality and design.

During production, Suzhou Menhow implements a comprehensive full - process validation. For key production line equipment involved in Printed ECG Electrode manufacturing and Liquid Silicone Rubber molding, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are carried out. This ensures that the production environment, including temperature, humidity, and cleanliness, is 100% compliant with medical standards for sterility and precision.​

A digital traceability system is in place. From the procurement of raw materials for printed circuits and silicone polymers for custom o rings to the finished products, every step can be traced. This meets the strict requirements of the EU Medical Device Regulation (MDR) and the U.S. FDA.​

There is also a continuous improvement mechanism. Quarterly updates to quality control plans have led to a 65% reduction in customer complaint rates over the past three years. This ensures that the quality of medical electrode and silicone rubber products keeps improving to better serve the medical device industry.

Looking ahead, Suzhou Menhow aims to ensure our products consistently meet the increasingly stringent requirements of the medical industry, while further enhancing product quality and innovation capabilities. Suzhou Menhow will continue to collaborate with global clients, contribute to the development of the medical industry through its unwavering dedication to quality and innovation.

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Company Name: Suzhou Menhow Electronic Co., Ltd
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Country: China
Website: https://www.menhowsz.com/