Steps to schedule your medical device cybersecurity test:※
Schedule a 30-minute Discovery Session
We determine IF and HOW we can help
We provide a Tailored Proposal
Together, we review the Proposal
Blue Goat understands that the primary drivers for medical device cybersecurity testing are 1) to ensure patient safety and 2) to obtain FDA clearance through premarket submissions, such as PMA, 510(k), and De Novo. Our medical device cybersecurity assessments and penetration testing methodology are designed to provide 100% coverage, based on the latest FDA guidelines. Our medical device vulnerability and penetration testing services are also based on and cover the following:
- FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- FDA Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices
- The Open Source Security Testing Methodology Manual
- Penetration Testing Execution Standard (PTES)
- U.S. NIST SP 800-115: Technical Guide to Information Security Testing and Assessment
- EU Medical Devices Regulation (MDR)
- UL 2900 set of standards (UL’s Cybersecurity Assurance Program)
- ANSI/ISA 62443-4-1
Blue Goat's Medical Device Vulnerability and Penetration Testing Overview※
Blue Goat Cyber’s Vulnerability and Penetration Testing Service is designed to adhere to the stringent requirements set forth by ANSI/ISA 62443-4-1, ensuring that medical device manufacturers meet and exceed contemporary cybersecurity standards. This detailed service offering is crafted to identify, evaluate, and mitigate potential vulnerabilities within medical devices through targeted analyses and testing techniques. Below is an enhanced overview of our service components:
- Abuse or Misuse Cases, Malformed and Unexpected Inputs: By simulating a variety of abuse or misuse scenarios, including providing malformed and unexpected inputs, our team assesses the device’s resilience and its ability to handle potential attack vectors securely.
- Robustness and Fuzz Testing: We leverage robustness testing and advanced fuzz testing to uncover coding errors and security gaps typically hidden under normal operational scenarios.
- Attack Surface Analysis: An exhaustive evaluation of the device’s attack surface is performed to identify all conceivable entry points for attackers, assessing the security implications associated with each.
- Vulnerability Chaining: Our cybersecurity experts investigate the interconnection between individual vulnerabilities, understanding how they might combine to amplify the risk and impact of potential attacks.
- Closed Box Testing of Known Vulnerability Scanning: Adopting a closed-box approach, we employ scanning techniques for known vulnerabilities without prior knowledge of the software code or architecture, effectively mimicking the perspective of an external attacker.
- Software Composition Analysis (SCA): Our SCA includes a detailed analysis of binary executable files alongside the generation of a Software Bill of Materials (SBOM) and analysis of Software of Unknown Pedigree (SOUP). This process is critical for documenting, tracking, and assessing software components and their associated vulnerabilities within the device.
- Static and Dynamic Code Analysis: The service encompasses both static (code analysis without execution) and dynamic (code analysis during execution) approaches to pinpoint vulnerabilities. This includes specific tests to identify hardcoded, default, easily guessed, and easily compromised credentials.
- Comprehensive Penetration Testing: Tailored to uncover and characterize security-related issues, our penetration testing focuses on discovering and exploiting the product’s security vulnerabilities. This comprehensive testing employs various methodologies to offer a complete assessment of the device’s cybersecurity posture.
Our penetration test reports are meticulously detailed, highlighting the independence and technical expertise of our testers, the scope and duration of the testing, the methodologies used, and a thorough review of the test results, findings, and observations.
Choosing Blue Goat Cyber means partnering with a leader in medical device cybersecurity, equipped with the expertise and specialized services required to navigate the complexities of FDA compliance. Our approach enhances the security and reliability of medical devices, ensuring they meet the highest standards of safety and effectiveness in the face of evolving cyber threats.
Latest FDA Guidance for Medical Device Security Testing※
FDA recommends that the following types of testing, among others, be considered for inclusion in the submission:
FDA 建议考虑将以下类型的测试纳入提交的文件中：
- Security requirements/安全要求
Manufacturers should provide evidence that each design input requirement was implemented successfully.
制造商应提供证据证明每项设计输入要求均已成功实施。
Manufacturers should provide evidence of their boundary analysis and rationale for their boundary assumptions.
制造商应提供其边界分析的证据以及边界假设的理由。
- Threat mitigation/威胁缓解措施
Manufacturers should provide details and evidence of testing that demonstrates effective risk control measures according to the threat models provided in the global system, multi-patient harm, updatability and patchability, and security use case views.
制造商应提供测试的详细信息和证据，以证明根据全球系统中提供的威胁模型、多患者伤害、可更新性和可修补性以及安全用例视图，采取了有效的风险控制措施。
Manufacturers should ensure the adequacy of each cybersecurity risk control (e.g., security effectiveness in enforcing the specified security policy, performance for maximum traffic conditions, stability, and reliability, as appropriate).
制造商应确保每个网络安全风险控制的充分性（例如，执行指定安全策略的安全有效性、最大流量条件下的性能、稳定性和可靠性）。
- Vulnerability Testing/漏洞测试 (section 9.4 of ANSI/ISA 62443-4-1)
Manufacturers should provide details and evidence of the following testing and analyses:
制造商应提供以下测试和分析的详细信息和证据：
Abuse or misuse cases, malformed and unexpected inputs
滥用或误用案例、格式错误和意外的输入
Robustness
鲁棒性
Fuzz testing
模糊测试
Attack surface analysis
攻击面分析
Vulnerability chaining
漏洞利用链
Closed box testing of known vulnerability scanning
已知漏洞的黑盒测试
Software composition analysis of binary executable files
可执行文件的软件架构分析
Static and dynamic code analysis, including testing for credentials that are “hardcoded,” default, easily guessed, and easily compromised.
静态和动态代码分析，包括测试“硬编码”、默认、容易猜测和容易泄露的凭据。
- Penetration testing/渗透测试
The testing should identify and characterize security-related issues via tests that focus on discovering and exploiting security vulnerabilities in the product.
测试应通过侧重于发现和利用产品中的安全漏洞的测试来识别和表征安全相关问题。
Penetration test reports should be provided and include the following elements:
应提供渗透测试报告并包括以下内容：
Independence and technical expertise of testers
测试人员的独立性和技术专长
Scope of testing
测试范围
Duration of testing
测试持续时间
Testing methods employed; and
采用的测试方法；和
Test results, findings, and observations
测试结果、发现和观察结果
