FDA Cybersecurity Compliance

Avoid Delays, Reduce Your Team’s Workload, and get FDA Clearance On the First Try

Trusted by medtech leaders who don't want cybersecurity to derail their FDA clearance

Distraught entrepreneur trying to figure out cybersecurity

Cybersecurity Shouldn’t Delay Your FDA Submission

Startups get stuck with FDA questions they didn’t expect. Security architecture views, threat models, cybersecurity management plan, pen test results… the list goes on.

Your team’s time is too valuable to waste decoding FDA guidance documents and international standards. Let us carry the cybersecurity burden while you stay focused on innovation.

Avoid Costly Delays

FDA requires more than a dozen cybersecurity attachments during a 510(k) submission. 

CyberMed prepares them for you.

FDA eSTAR Cybersecurity Documents Required

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 12 attachments for 510(k) submissions on eSTAR.

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

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
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
CyberMed analyzes your system to provide actionable insights, helping you implement effective security solutions that comply with industry standards.