Capabilities / MED
Medical Device Security Testing
Firmware and device security validation to meet FDA premarket submissions and ISO 13485 standards.
Scope of Assessment
We audit patient monitors, infusion pumps, and implantable hardware. We check firmware encryption, test wireless networks, and map security structures to satisfy FDA premarket guidelines.
FDA cybersecurity compliance check
Bluetooth / NFC communication safety
Firmware code updates validation
Local data protection audits
Engagement Details
Audit Duration12-18 Business Days
Lead CredentialsOSCP / OSWE / CISSP Certified
Retests Included1 Free Retest (within 30 days)
Frequently Asked Questions
Do you prepare reports for FDA audits?
Yes. Our final reports match FDA premarket cybersecurity guidelines to simplify compliance.
Let's map out your testing strategy.
Have a custom compliance framework or specific targeting parameters? Schedule a scoping session with our senior offensive leads.