Bittele Electronics Inc., a Toronto-based manufacturing firm specializing in prototype and low-to-mid volume printed circuit board (PCB) assembly, announced today that it has achieved the ISO 13485 certification of its Markham, Canada PCB manufacturing facility. This achievement confirms the safety and reliability of its PCB manufacturing processes for medical devices.
ISO 13485 is an international standard for quality management in the medical device industry. Created by the International Organization for Standardization (ISO), the standard is designed to ensure the quality of medical device design, development, and manufacturing.
"Bittele Electronics is proud to announce the recent ISO 13485 certification of its Markham, Canada facility," said Ben Yang, CEO of Bittele Electronics. "With this certification, you can be rest assured your PCBs for medical devices will be assembled to the highest level of quality," added Mr. Yang.
To earn the certification, companies must show that the Quality Management Systems of their products or services repeatably meet customer and regulatory requirements. The ISO 13485 certification highlights the quality of the practices and processes used by Bittele Electronics to manufacture PCBs for medical devices. "Bittele has a history of high-quality HDI PCB assembly, and our new certification ensures the boards we assemble meet regulatory requirements. From prototype to mid-volume production, Bittele can meet your medical Printed Circuit Board Assembly needs," said Mr. Yang.
About Bittele Electronics
In business since 2003, and based in Toronto, Canada, Bittele Electronics has established itself as a reliable, full turn-key PCB service provider and a one-stop Printed Circuit Board manufacturing and assembly company. All of Bittele's services are supported by extensive quality control. Its manufacturing plants are ISO9001-certified. They are in compliance with IPC-A600 and IPC-A610 Acceptability of Printed Boards standards.
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