TORONTO – Bittele Electronics, a Canadian turn-key PCB contract manufacturer, with expertise in prototype and low-to-mid production of printed circuit boards, is pleased to report that it has been renewed for the ISO 13485 certification for its Shenzhen, China PCB production plant.

"I am extremely pleased to announce our ISO 13485 re-certification," says Bittele CEO Ben Yang. "This renewal demonstrates to our clients that the PCBs for medical devices we manufacture for them will be produced with maximum quality based on repeatable and dependable processes."

ISO 13485: 2016 is a global quality standard that establishes the prerequisites for quality management applicable to medical device manufacturing, as detailed by the International Organization for Standardization (iso.org).

"The ISO 13485 certification is central to our pledge to the highest product quality while continuing to pursue improvements of our manufacturing methods," says Mr. Yang. "Bittele has a long record of top-quality HDI PCB manufacturing and the renewal of this certification ensures the PCBs we manufacture conform to regulatory standards. From prototype to mid-level production quantities, Bittele can satisfy your Medical Device PCB requirements."

In addition to Bittele's ISO 13485:2016 re-certification, it also possesses other ISO quality certifications, such as the ISO 9001:2015 (Markham, Canada) and the ISO 9001:2015 (Shenzhen, China).

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