Medical Device Academy primarily works with medical device startup companies that are developing their first product and need help obtaining 510k clearance for their device. The hottest trend in medical devices is adding wireless functionality to existing electromedical devices and developing software applications for sharing patient data with physicians. Some of our clients are not familiar with the standard for medical device software lifecyle management [i.e. IEC 62304 ed 1.1 (2015)], and almost 100% of our clients need help with documentation of cybersecurity risks and developing a plan for postmarket management of cybersecurity for their device.

If any of the following attributes are applicable to your medical device, then cybersecurity data is required in your 510k submission:

Cloud communication
Network connection (active or not)
Wireless communication in any form
USB/serial ports/removable media
Software upgrades (this includes patches)

You might also be interested in purchasing the associated procedure and work instruction:
(SYS044) https://www.medicaldeviceacademy.com/...
(WI007) https://medicaldeviceacademy.com/cybe...