Medical software manufacturers must meet the legal requirements for software components in order to “approve” their devices. This article presents these requirements and gives seven tips on how to fulfill them quickly and easily. 1. What software components / items are There are different definitions of “software component”, also referred to as software items as…
DetailsAnytime you want to launch a medical device on the market, you quickly come to the question of which legal regulations you have to comply with. This article will give you answers and present the seven steps to quickly place your devices on the market in compliance with the law. Step 1: Determine if the…
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