Kari said:
As a contract manufacturer, we only build to specs provided by our customers (we do not do any design work) . For the most part, we assemble circuit boards, however we do have a couple of customers for whom we build finished devices.
Given this, we really have no idea of what the potential risks would be to patients if defects go undetected. Therefore, wouldn't it be logical/acceptable , for our risk management program to focus on minimizing risks to the product itself? (i.e., defect prevention, etc.)
Thanks for your assistance/advice.
Kari
Given this, we really have no idea of what the potential risks would be to patients if defects go undetected. Therefore, wouldn't it be logical/acceptable , for our risk management program to focus on minimizing risks to the product itself? (i.e., defect prevention, etc.)
Thanks for your assistance/advice.
Kari