Medical Device Security Testing
Get the independent cybersecurity evidence the FDA expects in your medical device submission.
Overview
Medical device security testing is regulator-aligned cybersecurity assessment of connected medical devices, covering firmware, wireless interfaces, companion apps and backend services. 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. Penetration testing identifies weaknesses across hardware, firmware, software, wireless communications and the connected healthcare ecosystem, evaluating both device-level and connected-system security. 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
Our testing and artifacts are built to align with current FDA premarket guidance, section 524B and AAMI TIR57, and are traceable to your threat model and risk assessment, reducing the risk of deficiency letters.
AAMI TIR57 and FDA expectations call for testing by a team with no product-development involvement, ensuring unbiased findings and regulatory credibility.
Medical devices may face risks 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.