FDA Cybersecurity Testing Requirements - Interview with Red Sentry
Ғылым және технология
In the past, the FDA has required medical devices with wireless functionality to provide two cybersecurity documents in 510(k) submissions:
➤ Risk management summary for cybersecurity
➤ Cybersecurity management plan
In FY 2024 (i.e., next week), the FDA will start requiring cybersecurity testing in 510(k) submissions. The FDA has specifically identified:
➤ Vulnerability Testing
➤ Penetration Testing
The new FDA cybersecurity guidance can be downloaded from this link:
➤ medicaldeviceacademy.com/wp-c...
We also have procedures for cybersecurity and software validation:
➤ medicaldeviceacademy.com/cybe...
➤ medicaldeviceacademy.com/soft...
Many of our clients are struggling to meet this new testing requirement because it requires qualified cybersecurity experts independent from your development team to do the penetration testing. Today we are interviewing Valentina Flores, who is the CEO of Red Sentry. She is going to introduce her company and help us understand how they help companies with this testing.
If you are interested in scoping your pentest project, please use the following link:
➤ redsentry.typeform.com/Scoping
You can also email Red Sentry directly: hello@redsentry.com
Please type your cybersecurity questions in the comment section below.
Пікірлер: 11
Thank you for taking the time to do this interview Valentina. We really appreciate your help.
Loved the conversations, and the Q&A! Thanks for having us!
@MedicalDeviceAcademy
9 ай бұрын
Looking forward to a new cybersecurity topic next month. Maybe someone will post a great question in the comments for us to address next month.
This webinar was very informative. Looking forward to future ones. Thank you Rob and Red Sentry!
@MedicalDeviceAcademy
9 ай бұрын
Thank you. We are looking forward to more videos with Red Sentry too.
Thanks for this!
@MedicalDeviceAcademy
9 ай бұрын
Sure thing!
Thank you for helping us to understand. could you please let me know security control for this
@MedicalDeviceAcademy
4 ай бұрын
There are 8 security controls that must be included as a minimum. Those are included in the eSTAR and the help Java script window explains each one. The list of 8: A) Authentication controls: B) Authorization controls: C) Cryptography controls: D) Code, data, and execution integrity controls: E) Confidentiality controls: F) Event detection and logging controls: G) Resiliency and recovery controls: H) Firmware and software update controls:
any specfice requriement for tester to be certification for testing medical device
@MedicalDeviceAcademy
4 ай бұрын
Great question. The FDA states that the qualifications of the tester need to be documented, but the requirements do not include specific training in medical devices.