5 reasons FDA will refuse your 510(k) application due to cybersecurity deficiencies
Over the past decade, the FDA has steadily increased the degree of scrutiny applied to
Over the past decade, the FDA has steadily increased the degree of scrutiny applied to
Secure software updates are essential for protecting medical devices. As technology continues to advance, the
Section 524B of the Food, Drug, and Cosmetic Act (FD&C Act) requires manufacturers to ensure