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

"Our device was cleared before the FDA updated its cybersecurity guidance in 2023. When we submitted an application to expand our indications, FDA sent a host of cybersecurity questions. CyberMed quickly prepared the documentation we needed to support clearance. When it comes to medical device cybersecurity, these guys are legitimate experts."

"The CyberMed team is sharp, knowledgeable, and great to work with. They quickly reviewed our documentation, performed a cybersecurity gap analysis, and created a clear plan to secure our system and meet FDA requirements. Their expertise and efficiency made a huge impact—I highly recommend them to any medical device company."

"For sophisticated systems that include embedded software, mobile applications, and cloud, CyberMed's expertise in cybersecurity is truly unparalleled in the industry. They've been a trusted partner for years and I couldn't recommend them more highly. Take it from someone who's been in IT and security for more than three decades"

"As the founder and publisher of MedTech Leading Voice, I have my finger on the pulse of the medical devices industry. With FDA's recent focus on cybersecurity, any medical device company hoping to commercialize a product with software needs a security expert on their side. CyberMed is unsurpassed in the industry. Their team is next level."

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.

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.