IS THERE SOFTWARE IN YOUR MEDICAL DEVICE?

FDA's Cybersecurity Requirements Apply.

An ostrich with its head in the sand representing MedTech executives who want to avoid thinking about cybersecurity

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.

FDA eStart cybersecurity attachments

YOU DON’T HAVE TO GO IT ALONE

(and you shouldn’t)

Cybersecurity Consulting
If your team has deep software expertise, but lacks cybersecurity expertise, we're here to help.

We work closely with your team to identify vulnerabilities and implement robust controls.
FDA Documentation
If your device has software, FDA requires a dozen attachments for 510(k) submissions on eSTAR.

We prepare all the cybersecurity documentation so your team can focus on product design.
Cybersecurity Testing
Your medical device requires independent cybersecurity testing, per FDA guidance.

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
Our pen testing services uncover critical vulnerabilities in your medical devices, providing detailed reports and remediation strategies to enhance security.
Fuzz Testing
Fuzz testing helps identify unexpected vulnerabilities in your software, ensuring robust security measures are in place to protect against potential threats.
Security Analysis
Our team analyzes your system to provide actionable insights, helping you implement effective security solutions that comply with industry standards.

Client Feedback

Our clients trust us to secure their medical devices effectively.