Tempo Automation Receives ISO and IPC Certifications for Medical Device and Aerospace Manufacturing
Tempo is the third company in the world to be recognized as an IPC certified site for assembly standard IPC J-STD-001 Space and Military Applications Electronic Hardware Addendum; company also received the J-STD-001/610 Class 3 assembly standard certification.
San Francisco – June 4, 2019 — Tempo Automation, the world’s fastest electronics manufacturer for prototyping and low-volume production of printed circuit board assemblies, announces today that its San Francisco-based automated factory is now ISO 13485 certified and IPC J-STD-001/610 Class 3 certified. It is the third company in the world to receive IPC site certification for the J-STD-001 Space/Military Addendum assembly standard. ISO 13485 certification recognizes the company’s quality management system and ability to provide medical devices and related services that meet customer and applicable regulatory requirements. This includes production and testing processes and following rigorous manufacturing and quality process audits.
“The opportunities for electronics growth in the emerging medical technology industry continue to be unveiled as advancements designed to improve the quality and length of life continue to require evolving methods, equipment and capabilities,” said Brady O. Bruce, Tempo Automation vice president of marketing. “Regulatory requirements from the FDA and other governing bodies drive the need for faster product turnover and development for manufacturers to remain competitive. ISO 13485 certification validates our commitment to the medical technology industry and our support of helping customers, such as GE Healthcare, accelerate their time-to-market and create technology that will change lives. The IPC site certification is an important recognition for the aerospace and defense industry. Together these certifications allow us to help engineers with complex electronics needs innovate across many industries.”
“Different from other audit programs, IPC’s Validation Services Programs uniquely provides technical and in-depth assessments of products and processes in accordance with IPC standards,” said Randy Cherry, IPC director of Validation Services. “We are pleased to especially recognize Tempo Automation for becoming a member of IPC’s network of trusted QML suppliers.”
ISO 13485 certification is a required quality management standard for the production of medical devices. This certification validates Tempo’s quality management system and commitment to developing PCBA (printed circuit board assembly) for the medical technology industry, for both prototyping and small-lot manufacturing.
IPC is the global trade association serving the printed board and electronics assembly industries, establishing manufacturing standards and certification accepted worldwide. Tempo has been recognized as an IPC trusted supplier for this pair of assembly standards: IPC-A-610, Acceptability of Electronic Assemblies and IPC J-STD-001 Requirements for Soldered Electrical and Electronic Assemblies.
Tempo Automation creates factory automation software and deploys it in its own state-of-the-art PCBA plant to help leading companies in high-growth markets, including medical technology, aerospace and defense, industrial automation, and autonomous and electric vehicles. With its proprietary software-driven platform, web portal and state-of-the-art digital PCBA factory, Tempo can build and deliver high complexity printed circuit board assemblies in days instead of the weeks that customers are traditionally accustomed to waiting.
For more information about Tempo’s IPC J-STD-001 Space and Military Applications Electronic Hardware Addendum certification, visit the IPC website.