Electronic Products & Technology

Bittele achieves ISO 13485 cert

Quality certification is for medical printed board assemblies

December 24, 2020  EP&T Magazine

Bittele Electronics, a Toronto-based Turn-key pcb assembly firm specializing in prototype and low-to-mid volume printed circuit board assembly (pcba), announced that the company has received the ISO 13485 certification for its Shenzhen, China manufacturing facility. 

“We are very pleased to achieve our ISO 13485 certification,” said Bittele CEO Ben Yang. “With this certification, our customers can be confident that their PCBs for medical devices will be assembled to the highest level of quality standard with repeatable and reliable results.”

ISO 13485: 2016 is an internationally recognized standard that sets out the requirements for a quality management system specific to the medical devices industry, according to the International Organization for Standardization (iso.org).

“Earning the ISO 13485 certification is key to demonstrating our commitment to quality management and supports our belief in continually improving our processes,” said Mr. Yang. “Bittele has a history of high-quality HDI PCB assembly, and this new certification allows the boards we assemble to meet regulatory requirements. From prototype to mid-volume production, Bittele can meet your Medical PCBA needs,” Yang adds.

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Besides its recent ISO 13485:2016 certification, Bittele Electronics also holds additional ISO quality certifications, including ISO 9001:2015 (Markham, Canada) and ISO 9001:2015 (Shenzhen, China).

 


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