Medical devices are classified into Classes 1 through 4: Class 1 (一般医療機器; general medical device), Class 2 (管理医療機器; controlled medical device), Class 3 (高度管理医療機器; highly controlled medical device), and Class 4 (高度管理医療機器; highly controlled medical device). Definitions are as follows...
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…




