In fact, effective risk management can lead to improved quality management. Of the many regulatory requirements for medical device development, the most directly focused on safety are ISO 13485 and ISO 14971, which provide guidelines for quality management and risk management, respectively. Therefore, safety is the primary concern during the design, manufacturing, and testing of electronic devices and PCBs intended for medical use. Medical devices are intended to support, enhance, or save lives. When it comes to medical devices, the risk involved cannot be overlooked nor trivialized. ![]() There is another attribute of life that in many cases is overlooked or regarded as negligible: the fact that every action undertaken involves some degree of risk. ![]() Even so, it is hard to dispute its veracity. Obviously, this is a sarcastic attempt to demonstrate the extent to which the Internal Revenue Service (IRS) will go to ensure that your financial contribution to our government’s operations is not overlooked. ![]() Some people say that the only constants in life are that you will die and you must pay taxes.
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