FDA Cybersecurity Testing Requirements - Interview with Red Sentry

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:
➤ https://medicaldeviceacademy.com/wp-c...

We also have procedures for cybersecurity and software validation:
➤ https://medicaldeviceacademy.com/cybe...
➤ https://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:
➤ https://redsentry.typeform.com/Scoping

You can also email Red Sentry directly: [email protected]

Please type your cybersecurity questions in the comment section below.