IS THERE SOFTWARE IN YOUR MEDICAL DEVICE?
FDA's Cybersecurity Requirements Apply and CyberMed Can Help.

FDA’s 2023 Cybersecurity guidance document states:
“This guidance document is applicable to devices… that contain software (including firmware) or programmable logic. The guidance is not limited to devices that are network-enabled or contain other connected capabilities.”
But fear not. CyberMed can help.
Avoid Costly Delays
FDA requires more than a dozen cybersecurity attachments during a 510(k) submission.
CyberMed prepares them for you.
- Without the attachments, you can't submit.
- If your documents are inadequate, FDA will "Refuse to Accept".
- If FDA deems security risks unacceptable, you may need to redesign and retest.

Avoid Costly Delays
FDA requires more than a dozen cybersecurity attachments during a 510(k) submission. CyberMed prepares them for you.
- Without the attachments, you can't submit.
- If your documents are inadequate, FDA will "Refuse to Accept".
- If FDA deems security risks unacceptable, you may need to redesign and retest.

YOU DON’T HAVE TO GO IT ALONE
(and you shouldn’t)

Cybersecurity Consulting
We work closely with your team to identify vulnerabilities and implement robust controls.

FDA Documentation
We prepare the cybersecurity documentation so your team can focus on product design.

Cybersecurity Testing
We perform fuzz and pen testing on web, mobile, cloud, and embedded systems.
Comprehensive Cybersecurity Testing
CyberMed’s testing services are designed to identify and mitigate vulnerabilities in your medical devices. We offer fuzz and penetration testing to ensure your app, cloud, and embedded systems are secure.

Penetration Testing

Fuzz Testing

Security Analysis
Client Feedback
CyberMed’s clients trust us to secure their medical devices effectively.



