A number of emerging challenges face medical system designers as they move to multi-core and virtualized architectures. At the same time, as medical devices become more connected into M2M, cloud, or traditional IT infrastructure, achieving cybersecurity as part of the system’s functional safety requirements becomes increasingly important.
Designers must ensure compliance to standards such as FDA and IEC 62304, and such regulatory bodies today are considering more often the impact of security risks on safety compliance, factoring security threat vector probabilities into failure mode considerations. Complications such as those presented by reusing pre-existing non-qualified software or software of unknown pedigree (SOUP) provide additional challenges to medical design teams.
Wind River® medical system platforms and profiles enable our customers to develop compliant, safe, and secure connected devices and systems. The Wind River Professional Services Medical Practice provides services to help medical device and system designers plan, develop, and manage safe, secure, reliable, and compliant platforms and solutions, focusing on the following segments:
Planning and Architectural Services
We provide system-level analysis to ensure that end-to-end system-level requirements for compliance, connectivity, manageability, and security are planned for. Architecture assessment and design services include the following:
- Storyboarding, benchmarking, and requirements capture
- Hardware/software tradeoff analysis
- Design for verification and validation and life cycle planning
- Graphical user interface development and optimization
- Safety, security, and standards compliance
- Development process review
- Assistance with risk planning
- Vulnerability analysis
Development and Integration Services
Customers rely on us to design, build, integrate, and test kernel, middleware, and application-level software to assist in achieving their most critical medical safety standards.
- Board support packages (BSPs), drivers, porting, and middleware integration
- Migration services and performance optimizations
- Validation support
- Validation and verification design, planning, and test execution
- Life cycle tools integration (Wind River Simics, Wind River Test Management, etc.)
- Artifacts generation
Long-Term Platform Management Services
We work with your team and the certifying authority to establish a regular audit process, ensuring that procedures for configuration management are established and followed, and keeping the deployed systems in compliance and relevant for efficient re-use in the future.
- Long-term management of the operating system, security tools, connectivity, manageability, and virtualization
- Security and safety audits of code and development procedures, toolchains, and platforms
Cybersecurity threats are numerous today: virus backdoors, external exploitations, insider manipulations, unauthorized access, penetration, routing and IP spoofing, communications disruption, hardware damage or theft. Wind River offers many methods to prevent the risk and lessen the impact if the threat vector is realized. For example, Secure Remote Management enables the following features:
- Trusted boot
- Secure update
- Resource protection
- Policy management
- Encryption protocols and methods
- MDM policy management
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