Why Medical PCBA Needs ISO13485 Qualification Certification

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2023-11-09 18:16:12

In our life, PCBA is widely used. In particular, the development of medical technology has benefited too many people, and it is mainly due to the improvement of SMT technology, which can promote the maturity and stability of PCBA control boards. So why does medical PCBA processing require ISO13485 qualification certification?

1. The manufacturing process of medical PCBA involves a variety of medical electronic equipment and materials, such as sensors, displays, electronic components, connecting wires, etc. The quality of these devices and materials directly affects the quality and safety of medical device. The ISO13485 standard puts forward detailed requirements and standards for the production process of medical PCBA processing, including production equipment, raw materials, technological process, quality control, etc., to ensure the quality and safety of medical PCBA processing.

2. The quality and safety of medical devices is one of the key factors affecting the safety and health of patients. If the quality and safety of medical PCBA processing cannot be guaranteed, it will bring potential health risks and safety hazards to patients.

3. The ISO13485 standard is an international general medical electronic equipment quality management system standard, which has been adopted by medical equipment manufacturers in many countries and regions. Medical PCBA has obtained ISO13485 qualification certification, which can prove the quality and management level of medical equipment production of manufacturers, thereby improving the reputation and market competitiveness of medical equipment.

HoYoGo is an international, professional and reliable PCB manufacturer, we have obtained ISO13485 qualification certification, and we have consistently followed the highest industry standard certification requirements for production teams, engineering teams, and procurement teams. We have long-term experience accumulation and professional process knowledge in medical PCBA assembly.