Systems Engineering, Validation, and Compliance

Overview:

Robust systems validation, strict compliance adherence, and security-centric design are essential for high-assurance medical, telecom, federal, and autonomous systems.

Key topics include end-to-end systems validation, regulatory compliance (NIST, ISO, IEC) for medical, telecom, and federal projects, and secure design for autonomous and embedded systems. Best practices in validation emphasize Hardware-in-the-Loop (HIL) testing, iterative scenario-based approaches, full test coverage with traceability, automation, and integrated security testing. Regulatory frameworks such as NIST 800-53, ISO/IEC 27001, and ISO/IEC 17025 are critical for ensuring security, risk management, and testing accreditation in high-assurance domains. Secure design mandates traceable, auditable AI/ML systems, adherence to safety standards (ISO 26262, DO-178C, EN 50128), and resilient architectures capable of real-time cyber threat response.

Why you should Attend:

Are your products truly market-ready, or are unseen gaps in validation and compliance threatening your launch-and your reputation? In today’s world of ever-evolving regulations, rising cybersecurity risks, and complex hardware/software integration, one missed requirement or weak design can lead to costly delays, audit failures, or security breaches that competitors will exploit. Don’t risk falling behind-join us to learn essential strategies, proven frameworks, and actionable best practices to safeguard your systems and business. Secure your spot now before avoidable issues turn into critical failures.

Areas Covered in the Session:

Here is a concise overview of the core areas covered in the session, focusing on industry best practices and up-to-date guidance in systems engineering, validation, compliance, and security for complex hardware/software/firmware and autonomous systems.
End-to-End Systems Validation: Best Practices - Effective validation requires a clearly defined scope using realistic use cases and operational scenarios to ensure full coverage. Cross-functional collaboration among hardware, software, and firmware teams is essential to avoid integration issues. Automation through CI, HIL simulations, and test pipelines enables scalable, repeatable validation while detecting issues early. Iterative testing with continuous analysis and refinement helps uncover regressions and ensures robust system performance.

Regulatory Compliance: NIST, ISO, IEC - NIST SP 800-53 defines mandatory cybersecurity controls for U.S. federal, medical, and government projects, covering access, encryption, and incident response. ISO/IEC 27001 is a global ISMS standard focused on structured risk management in sectors like healthcare, telecom, and federal. Conformance tools and audit support from NIST and industry standards help ensure accreditation, enhance safety, and build trust.

Secure Design and Validation for Autonomous and Embedded Systems - Software and AI validation now demands explainable, auditable AI (XAI), with practices like model freezing and traceable AI behavior becoming key for safety compliance. Hybrid approaches-combining static analysis, code coverage, and AI-specific validation-are essential to meet evolving standards like ISO 26262. Security is critical, requiring validation to include threat modeling, penetration testing, sensor attack scenarios, and firmware integrity checks to ensure resilience in AI-driven embedded systems

Key reference: 

• End-to-end validation best practices: IBM, McKinsey, HIL methodologies
• Regulatory compliance in Health/Medical/Federal: NIST SP800-53, ISO/IEC 27001, NIST HIT Certification
• Secure/Auditable AI and embedded validation: EU XANDAR project, Explainable AI for certification

Who Will Benefit:

• All