OnCore China Facility Achieves ISO13485 Certification


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OnCore Manufacturing LLC, a global supplier of electronic manufacturing services, announces that its manufacturing facility in Suzhou, China has been certified to ISO 13485:2012 quality management system for medical devices. The OnCore Suzhou site has also been certified by IPC to J-STD-001/IPC-A-610 Qualified Manufacturers List (QML) for electronics assembly.

ISO13485 outlines a comprehensive quality management system for the design and manufacture of medical devices. Achieving certification demonstrates a commitment for quality throughout the product development life-cycle of medical devices.

Achievement of the IPC QML requires passing an intensive audit process to IPC J-STD-001 standard that describes materials, methods and verification criteria for producing high quality soldered interconnections, and IPC-A-610, Acceptability of Electronic Assemblies. OnCore Suzhou is one of only two manufactures in China to achieve the QML certification.

"The recent certification brings all eight of OnCore Manufacturing sites to ISO 13485 compliance," stated David Busch, OnCore Vice President Medical. "It demonstrates OnCore's commitment to expanding our service offering for medical manufacturing with consistent processes at any of the OnCore sites worldwide."

"Completing these new milestones at our recently expanded Suzhou China location demonstrates OnCore's industry quality leadership and also creates alignment of our strategy with our customers seeking China medical product manufacturing," says David Brakenwagen, OnCore Manufacturing Senior Vice President of Sales and Marketing.

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