IS THERE SOFTWARE IN YOUR MEDICAL DEVICE?
FDA's Cybersecurity Requirements Apply.

FDA’s 2023 Cybersecurity guidance document flat out states:
“This guidance document is applicable to devices with cybersecurity considerations, including but not limited to devices that have a device software function or that contain software (including firmware) or programmable logic. The guidance is not limited to devices that are network-enabled or contain other connected capabilities.”
Avoid Costly Delays
FDA requires more than a dozen cybersecurity attachments during a 510(k) submission. We prepare 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 all the cybersecurity documentation so your team can focus on product design.

Cybersecurity Testing
We're experts at performing fuzz and penetration on web, mobile, cloud, and embedded systems.
Comprehensive Cybersecurity Testing Services
Our cybersecurity 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
Our clients trust us to secure their medical devices effectively.


