Why do medical equipment wiring harnesses and cable assemblies need to undergo ISO 13485 certification?
Publish:
2025-06-11 15:47
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ISO 13485 is a manufacturing certification for medical devices, which ensures that customers understand the regulations and procedures required for product development.This certification is applicable to wires and cables, connectors, surface mounts, cables harness, wire processing, wire harnesses and panel wire assemblies manufactured in the medical industry. SAISONIC was certified for ISO13485 medical device wiring harnesses and cable assemblies on April 15, 2013, providing services to all customers in the medical industry
The manufacturing of medical device wiring harnesses and cable assemblies and similar services requires a great deal of preventive and regulatory actions to provide the most effective products for customers and patients. Through various potential processes and safety measures, medical certification enables the quality management system to follow the established appropriate measures. As a medical component certification, ISO 13485 is beneficial to manufacturing plants and customers in providing transparent safety regulations.
After all, customers seeking manufacturers to complete various medical projects tend to cooperate with ISO13485 certified companies, as they can ensure the correct and effective processing of the wire harnesses and cable assemblies required for medical equipment.
The demand for medical products, services and industry manufacturers is a global and continuous market.
In order to attract customers from all over the world, the company must provide effective cable assemblies and wire harness products assembled by efficient processes. Medical certification provides customers with relief to understand the necessary manufacturing and assembly strategies. Similarly, manufacturers have gained more opportunities to enter the global market. With standard certification, companies can meet quality requirements and promote their services internationally. It is easier to acquire customers, and potential customers increase with the ability to expand globally.
Due to the effective safety measures in place, the ISO13485 certification for the manufacturing of medical wiring harnesses and cable assemblies has been obtained, proving that medical devices are safer and more effective. The medical industry requires a large number of preventive measures to ensure the success of all delivered products. In addition, the manufacturer provides transparent and reliable processes for every project and customer involving medical devices.
To obtain ISO 13485 certification, cable assembly and wiring harness manufacturers must meet regulatory requirements as well as essentially customer expectations. It can be said that the most crucial aspect of medical certification is the reputation of the medical service provider. In conclusion, the focus of the global medical industry is on safety and assembly requirements to claim a successful manufacturing process.
SAISONIC's expertise in medical wiring harness and cable assembly services
SAISONIC has held the medical ISO13485 certification for 12 years. The ISO certification attests to SAISONIC's pursuit of credibility, transparency, and high-quality wire harness and cable assembly products and services. In fact, among all medical projects, customer satisfaction and product functionality are the top priorities. For more information on medical cable assemblies and harness assembly services, please contact us.
Medical Cable & Wire Harness
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