MEDICAL DEVICE CYBERSECURITY FOLLOWING LATEST FDA GUIDANCE
July 18, 2023 - CAEventura World
info@eventura.us
Phone:+1-416-915-4438
Medical devices using the software are similar to other computer software and systems; they can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. It is essential that companies establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program established must be carefully planned and executed. A formal hazard analysis must be conducted for each risk which must be communicated to device users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant to the FDA requirements.