Cybersecurity
Product Design
QDS: Protecting Medical Technology with Targeted Cybersecurity Solutions
In the rapidly evolving landscape of medical technology, cybersecurity is paramount to ensuring the safety, efficacy, and compliance of Software in Medical Devices (SiMD), Software as a Medical Device (SaMD), and Multiple Function Device Products. Qualified Data Systems (QDS) offers a comprehensive suite of Cybersecurity Services grounded in the principles of “Secure by Design, Secure by Default, and Secure for Compliance.” These services are tailored to meet the unique needs of medical device manufacturers, helping them to protect patient data, maintain regulatory compliance, and safeguard the integrity of their products throughout the total product lifecycle.
Core Services
Secure by Design
- Threat Modeling and Risk Assessment: QDS conducts thorough threat modeling and risk assessments during the early stages of software development. By identifying potential security risks and vulnerabilities upfront, we help design secure software architectures for SiMD, SaMD, and Multiple Function Device Products.
- Security Requirements Engineering: We assist in defining and integrating security requirements into your software development process, ensuring that security is considered at every stage, from design to deployment. Our approach ensures that your products are inherently secure against emerging threats.
- Security Architecture Review: Our experts review your software architecture to ensure it incorporates best practices in secure design. We focus on minimizing attack surfaces, enforcing the principle of least privilege, and ensuring secure data flows throughout the system.
Secure by Default
- Secure Configuration and Hardening: QDS provides secure configuration and hardening services, ensuring that your SiMD, SaMD, and Multiple Function Device Products are configured securely out of the box. This includes disabling unnecessary services, enforcing strong encryption protocols, and implementing robust access controls.
- Default Security Settings: We ensure that your products ship with secure default settings, reducing the likelihood of vulnerabilities being introduced during deployment. Our services include the development of secure configuration guides for end-users and healthcare providers.
- Automated Security Testing: QDS leverages automated security testing tools and techniques to identify vulnerabilities during the development process. This includes static and dynamic analysis, fuzz testing, and penetration testing, ensuring that your software is resilient to attacks.
Secure for Compliance
- Regulatory Compliance Alignment: QDS ensures that your cybersecurity practices align with regulatory requirements, such as FDA cybersecurity guidance, IEC 62304, AAMI TIR 57, IEC 62443, and ISO/IEC 27001. We help you navigate the complex regulatory landscape, ensuring that your products meet the necessary standards for security and compliance.
- Documentation and Audit Preparation: We provide comprehensive technical documentation support, including the development of cybersecurity risk management plans, incident response plans, and security testing records. QDS also prepares your organization for regulatory audits, ensuring that you can demonstrate compliance with cybersecurity requirements.
- Post-Market Surveillance and Incident Response: Our services extend beyond product launch, providing ongoing support for post-market cybersecurity activities. This includes continuous monitoring, vulnerability management, and incident response planning, ensuring that your products remain secure throughout their lifecycle.
Industry Focus
QDS specializes in providing cybersecurity services for the following areas:
- Software in Medical Devices (SiMD): Ensuring that embedded software in medical devices is secure, reliable, and compliant with industry standards.
- Software as a Medical Device (SaMD): Protecting standalone software applications that perform medical functions, ensuring they are secure and compliant throughout their lifecycle.
- Multiple Function Device Products: Addressing the unique cybersecurity challenges of products that combine multiple functions, including both medical and non-medical software components.
Value Proposition
QDS’s Software Assurance Services for non-product software offer the following benefits:
By integrating security into the design process (Secure by Design), we ensure that your products are fundamentally secure, reducing the need for reactive security measures.
With Secure by Default principles, your products are shipped with secure configurations, minimizing the risk of misconfigurations that could lead to security vulnerabilities.
Our Secure for Compliance services ensure that your cybersecurity practices meet or exceed regulatory requirements, reducing the risk of non-compliance and facilitating smoother regulatory approvals.
QDS provides a holistic approach to cybersecurity, covering everything from initial design to post-market surveillance, ensuring that your products are protected against evolving cyber threats.