This technical information has been contributed bySAN JOSE, Calif.—Bestronics has achieved ISO 13485 certification for its San Jose, Calif., facility, the company announced recently. ISO 13485 certification requires demonstration that a company’s quality management systems meet regulatory, safety, and quality standards for the design and manufacturing of products used in healthcare.
Bestronics Achieves ISO 13485 Certification
Certification marks continued expansion of the company’s medical devices and subsystem manufacturing for OEMs worldwide
“Customer trust is the foundation of Bestronics’ business,” said Bestronics President and CEO Nat Mani, in a statement. “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. The company describes its culture as “zero latency,” with mandated quality and continuous improvement processes embedded in manufacturing operations.
Bestronics (builtinthevalley.com) 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.
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