Medical Device Security Testing
Medical Device Security Testing
Get independent medical device penetration testing and cybersecurity evidence aligned with FDA premarket requirements for your medical device submission.
Overview
Medical device security testing is a cybersecurity assessment that identifies vulnerabilities in connected medical devices, including hardware, firmware, wireless interfaces, companion applications and backend systems. Independent of the development team, it produces the threat-modeling, vulnerability and penetration testing artifacts the FDA expects in premarket submissions and supports postmarket security. Medical device penetration testing evaluates exploitable vulnerabilities across device hardware, firmware, software, wireless communications and connected healthcare systems. This helps manufacturers understand their cybersecurity risks and improve overall security maturity.
Methodology & Standards
FDA premarket cybersecurity guidance (2023) and section 524B, AAMI TIR57, ISO 14971, IEC 62304, IEC 81001-5-1, plus IEC 62443 and UL 2900 where applicable.
What's Included
What You Receive
Frequently Asked Questions
Medical device penetration testing is an authorised security assessment that simulates real attacks against a connected medical device to find exploitable vulnerabilities. It covers device hardware, firmware, wireless communications, companion applications and the backend services the device depends on, and reports findings with proof of exploitability rather than scanner output.
It includes threat model and security risk assessment traceability, hardware and firmware assessment, wireless and communication protocol testing, companion application and backend testing, and a software bill of materials (SBOM). The artifacts are produced to align with current FDA premarket guidance and section 524B so they can be submitted as evidence.
For cyber devices, FDA premarket submissions including 510(k) are expected to contain cybersecurity documentation under section 524B: a threat model, a security risk assessment, an SBOM and evidence of testing. Our testing and artifacts are built to align with current FDA premarket guidance and AAMI TIR57, and are traceable to your threat model and risk assessment, reducing the risk of deficiency letters.
Testing is measured against FDA premarket cybersecurity guidance (2023) and section 524B, AAMI TIR57, ISO 14971, IEC 62304 and IEC 81001-5-1, with IEC 62443 and UL 2900 applied where relevant to the device and its environment.
Medical devices may face vulnerabilities such as insecure communications, weak authentication, firmware vulnerabilities, software flaws, and exposure through connected healthcare systems. Security testing helps identify and reduce these risks before deployment.