Bittele Electronics, a Canadian-based turn-key PCB contract manufacturer specializing in printed circuit boards for prototype and low-to-mid production, proudly announced the successful renewal of its ISO 13485 certification for its Shenzhen, China PCB production plant.
CEO Ben Yang expressed satisfaction with the re-certification, highlighting its importance for clients relying on Bittele’s PCBs for medical devices. “Our ISO 13485 re-certification demonstrates our commitment to producing high-quality PCBs for medical devices,” stated Yang. “It assures clients that our manufacturing processes adhere to stringent quality standards, ensuring reliability.”
ISO 13485:2016, established by the International Organization for Standardization (iso.org), sets quality management benchmarks for medical device manufacturing.
Yang emphasized the certification’s role in Bittele’s commitment to superior product quality and continuous improvements. “This re-certification reinforces Bittele’s track record in top-quality HDI PCB manufacturing, ensuring compliance with regulatory standards,” he affirmed. “From prototypes to mid-level production, Bittele caters to diverse Medical Device PCB needs.”
In addition to ISO 13485:2016, Bittele Electronics holds ISO 9001:2015 certifications for its facilities in Markham, Canada, and Shenzhen, China.
