Over the past decade, the FDA has steadily increased the degree of scrutiny applied to cybersecurity aspects of submissions.  From the guidance issued on this

A startup recently shared with us that they were considering incorporating remote software updates into their medical device. They knew this feature would add a

While remote software updates for medical devices have traditionally been seen as a convenient feature, the FDA now emphasizes their crucial role in safeguarding against

En una era en la que los dispositivos médicos están cada vez más interconectados y dependen del software, la ciberseguridad se ha convertido en un