For EMS providers and contract manufacturers, the International Standards Organization (ISO) 13485 Standard provides a considerable number of challenges. They all fall under the main category of quality management systems for medical electronics products. But now there is a new wrinkle associated with ISO 13485; this wrinkle isn’t in the books and is rarely spoken about.
But savvy OEMs know that this new and highly critical factor is synonymous with the quality and reliability theme of this standard. Wire-bonding technology is the new factor coming onto the PCB assembly floor, and its basic requirements are for high quality and reliability to further support ISO 13485.
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