by ptlsolut | Nov 14, 2023 | FDA Compliance, Medical Device Cybersecurity
As of Oct 1, lax cybersecurity is grounds for FDA rejection and potential criminal prosecution For years, the FDA has coaxed medical device makers to take cybersecurity seriously. A law ensuring cybersecurity for medical devices passed by Congress in Dec ‘22, had a...
by ptlsolut | Jan 31, 2022 | FDA Compliance
Warning letters issued by FDA to medical device manufacturers are a significant concern that can mean challenging times ahead for the manufacturer. Warning letters certainly have a negative stigma attached, and for good reason, as they are quite often a sign of...
