In September 2023, the FDA's issued guidance on "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" which outlined critical recommendations for medical device manufacturers to ensure the security and safety of their products. This comprehensive guidance applies to a wide range of devices, including those with software functions, programmable logic, or connectivity capabilities. After nearly two years of helping Medical Device manufacturers work through this guidance, we thought it would be helpful to share some of the key points that comprise this guidance.

In September 2023, the FDA's issued guidance on "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" which outlined critical recommendations for medical device manufacturers to ensure the security and safety of their products. This comprehensive guidance applies to a wide range of devices, including those with software functions, programmable logic, or connectivity capabilities. After nearly two years of helping Medical Device manufacturers work through this guidance, we thought it would be helpful to share some of the key points that comprise this guidance.

Source: SecurityInnovation
Source Link: https://blog.securityinnovation.com/navigating-the-fdas-cybersecurity-guidance-for-medical-devices