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Medical Device Industry

FDA-Ready Cybersecurity

For Medical Devices

Ensure your medical device meets FDA cybersecurity requirements with IntegSec's specialized vulnerability assessments and penetration testing services for device manufacturers.

Security Challenges Facing Medical Device Manufacturers

Medical device manufacturers face increasing regulatory pressure and cybersecurity threats as devices become more connected and the FDA strengthens its cybersecurity requirements.

FDA Premarket Cybersecurity Requirements

The FDA refuses 510(k) and PMA submissions with inadequate cybersecurity documentation, delaying market authorization and increasing development costs.

Postmarket Vulnerability Management

Manufacturers face ongoing obligations to monitor, identify, and address cybersecurity vulnerabilities throughout the entire device lifecycle.

Software Bill of Materials (SBOM)

The FDA now requires a detailed SBOM for all cyber devices, increasing transparency and vulnerability tracking obligations for manufacturers.

Connected Device Attack Surface

IoMT devices create expanded attack surfaces through wireless protocols, cloud connectivity, and hospital network integration.

FDA Cybersecurity Requirements

The FDA's premarket cybersecurity guidance (October 2023) and Section 524B of the FD&C Act require cybersecurity documentation for all cyber devices submitted for premarket authorization. Manufacturers must demonstrate that their devices are secure by design, and penalties for non-compliance include Refuse to Accept decisions on 510(k) and PMA submissions.

FDA Cybersecurity Guidance for Medical Devices
1-Feb

Premarket Submission Documentation

Cybersecurity risk assessment, threat modeling, and security architecture documentation required for 510(k) and PMA submissions.

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2-Feb

Security Testing & Verification

Penetration testing, fuzz testing, and vulnerability scanning to demonstrate device security.

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3-Feb

Software Bill of Materials (SBOM)

Complete inventory of commercial, open-source, and off-the- shelf software components included in the device.

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4-Feb

Postmarket Cybersecurity

Coordinated vulnerability disclosure policies, software update capabilities, and ongoing monitoring plans.

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How IntegSec Secures Medical Devices

Our specialized security services help medical device manufacturers identify vulnerabilities, meet FDA requirements, and protect patient safety.

Vulnerability Assessments

Systematic evaluation of your device's firmware, software, and network interfaces to identify security weaknesses before they reach the FDA or the market.

  • Device firmware and software analysis
  • Network protocol and API security testing
  • Wireless communication assessment (Bluetooth, Wi-Fi, Zigbee)
  • SBOM component vulnerability analysis
  • Risk-prioritized findings mapped to FDA guidance

FDA Alignment:Directly supports FDA premarket cybersecurity documentation requirements and Section 524B compliance for demonstrating device security.

Penetration Testing

Simulated real-world attacks against your medical device to validate security controls and uncover exploitable vulnerabilities before submission.

  • Device-level penetration testing
  • Cloud backend and API exploitation testing
  • Wireless protocol attack simulation
  • Authentication and access control testing
  • Detailed technical report for FDA submission

FDA Alignment:Satisfies the FDA expectation for security testing evidence in 510(k) and PMA cybersecurity documentation.

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WHY CHOOSE US

Why Medical Device Manufacturers Choose IntegSec

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FDA Submission Expertise

Reports structured for FDA premarket submission, directly addressing cybersecurity documentation requirements.

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Medical Device Specialization

Deep experience testing embedded systems, IoMT devices, wireless protocols, and clinical software.

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Patient Safety Focus

Testing methodologies designed to identify vulnerabilities that could impact patient safety or device efficacy.

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Regulatory-Ready Reports

Deliverables formatted to satisfy FDA reviewers, reducing submission delays and Refuse to Accept decisions.

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Secure Your Medical Device for FDA Submission

Don't risk an FDA Refuse to Accept decision. Partner with IntegSec to ensure your medical device meets all cybersecurity requirements.

 

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