Articles about Medical Device

Close up of hand touching smartwatch with health app on the screen, gadget for fitness active lifestyle.
Health IT 9 Min Read

FDA Releases Final Guidance on Clinical Decision Support Software as a Medical Device

December 8, 2022 Written by Juan Vasquez, Andrew Holm-Hansen

Quandary Peak’s review of FDA’s final guidance leads us to believe we could see meaningful expansion of the amount of CDSS qualifying as a medical device, which could subject many current and future CDS software applications to FDA oversight.

Medical devices hanging on wall
Health IT 7 Min Read

Understanding Medical Device Cybersecurity & the FDA’s Role

April 25, 2022 Written by Juan Vasquez

As medical devices evolve to better treat and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility…”