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 FDA Delays
FDA’s requires 12 cybersecurity attachments during a 510(k) submisssion.
- 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 probably 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.
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.
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.
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 software and embedded systems are secure.
Penetration Testing for Medical Devices
Our penetration testing services uncover critical vulnerabilities in your medical devices, providing you with detailed reports and remediation strategies to enhance security.
Fuzz Testing for Software Security
Fuzz testing helps identify unexpected vulnerabilities in your software, ensuring robust security measures are in place to protect against potential threats.
Security Analysis and Improvement
Our team analyzes test results to provide actionable insights, helping you implement effective security improvements and maintain compliance with industry standards.
Client Feedback
Our clients trust us to secure their medical devices effectively.
"Our device was cleared before the FDA updated its cybersecurity guidance in 2023. When we submitted an application to expand our indications, FDA came back with 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."
"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"
"CyberMed has been a trusted partner of our product development team for several years. We have valued their technical expertise, ability to help us troubleshoot issues and solve problems. Their QMS system and attention to detail in building out DHFs has been robust. They have also helped us learn quickly with early-stage exploration ."
