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Bestronics announced today that it has achieved ISO 13485 certification for its San Jose, CA facility. ISO 13485 certification requires the demonstration of quality management systems meeting regulatory, safety and quality standards for the design and manufacturing of products used in healthcare.
“Customer trust is the foundation of Bestronics’ business,” said Bestronics President and CEO Nat Mani. “Our customers rely on us to enforce quality processes that remove risk concerns from any product we supply throughout its lifecycle and to rest assured that those products meet global standards without issue. 13485 certification enables us to broaden the circle of trust we’ve established with bio medical customers to manufacture their complex products and provide more value-added services such as system level assembly and integration.”
In addition to the ISO 13485 certification, Bestronics is ISO 9001 certified, ITAR registered and offers a Class 10000 (ISO Class 7) Clean Room and ESD flooring throughout its facility. Bestronics features a zero latency culture with mandated quality and continuous improvement processes embedded in manufacturing operations.
Located in the heart of Silicon Valley, Bestronics provides a wide range of manufacturing, engineering, testing and material/program management services. Its customers include major original equipment manufacturers in instrumentation, power generation, energy management, communications, wireless, industrial and other markets.