1. Analyze Current Processes and Products 
Evaluate the organization’s existing development processes and/or product characteristics against the target safety standard (e.g., IEC 62304, ISO 14971, etc.). 
 
2. Identify Gaps 
Detect any non-conformities, deficiencies, or missing elements relative to the standard’s requirements. 
 
3. Discuss Findings and Recommend Actions 
Present the identified gaps to relevant stakeholders and provide practical recommendations to address each issue. 
 
4. Propose Action Plan and Align with Stakeholders 
Develop a prioritized, actionable roadmap for closing the gaps, ensuring alignment with internal teams (e.g., Quality, Engineering, Regulatory). 
 
5. Follow-Up on Actions 
Track progress on action items, support implementation, and verify closure of gaps through audits or reviews. 

We provide comprehensive safety analysis services across system, hardware, and software levels, tailored to meet the requirements of safety-critical domains such as automotive, aerospace, rail, medical, wind energy, and robotics. 
 
1. HARA / FHA 
Identify system hazards, assess risks, and define safety goals or top-level safety requirements based on operational scenarios. 
 
2. System FMEA 
Evaluate potential failure modes at the system and subsystem level, assess effects, and recommend mitigation actions. 
 
3. FMEDA 
Quantify hardware failure rates and diagnostic coverage to support safety metric calculations (SPFM, LFM, PMHF).  
 
4. eFMEA 
Analyze electrical-level faults (e.g., open/short circuits) in circuit design to ensure robustness and reliability. 
 
5. FTA 
Conduct top-down deductive analysis to identify root causes of hazardous system events using fault tree models. 
 
6. CPA / Software Safety Analysis 
Map software failure causes, control paths, and effects to ensure safe software behavior and proper error handling. 
 
7. DFA (Dependent Failure Analysis) 
Identify common cause and cascading failures due to shared resources or design dependencies and define independence measures. 
 
8. STPA (System-Theoretic Process Analysis) 
Use control theory and system interactions to identify unsafe control actions and define constraints, especially in software-intensive and autonomous systems. 

•  Software Requirements: Define safety requirements derived from system safety goals, ensuring traceability and compliance with ASIL. 
   
• Software Architecture: Design software architecture aligned with safety goals, incorporating safety mechanisms such as fault tolerance and error handling. 
   
• Software Detailed Design: Create detailed software design, ensuring it meets the defined safety requirements and incorporates appropriate safety measures. 
   
• Software Development: Implement and verify safety-critical software functions, ensuring compliance with ISO 26262 throughout the development lifecycle.

1. Safety Goal (SG) 
Derive safety goals (SGs) with severity, exposure, controllability 

2. Functional Safety Concept (FSC) 
Define Functional Safety Requirements (FSRs) at the system level based on SGs and hazards 

3. Technical Safety Concept (TSC) 
– Translate FSRs into Technical Safety Requirements (TSRs) 
– Add requirements to meet diagnostic coverage, fault detection time, safe states 

4. Hardware Safety Requirements (HSRs) 
– Derived from allocated TSRs 
– Support FMEDA and architectural metrics 

5. Software Safety Requirements (SSRs) 
Derived from allocated TSRs

Verification Activities 

Focus on ensuring that the product is built correctly based on its safety requirements and specifications: 

– Traceability Analysis: Establish and verify end-to-end traceability from safety goals to requirements, design, implementation, and test cases. 

– Test Case Review: Review test cases to ensure they adequately cover and correctly interpret safety requirements. 

– Design and Code Reviews: Conduct static verification activities including peer reviews, formal inspections, and coding guideline checks (e.g., MISRA C/C++). 

– Documentation Review: Evaluate completeness, correctness, and consistency of safety work products. 

Validation Activities 

Focus on ensuring that the right product has been built and that it meets its intended safety purpose in its target environment: 

– Unit Testing: Verify individual software components or functions for correctness and robustness. 

– Integration Testing: Validate interactions between integrated components/modules, including fault propagation paths. 

– Qualification Testing: Validate system behavior under realistic and fault conditions to confirm it meets the safety goals and intended use.

Review of Safety Artifacts: 

Conduct thorough evaluations of safety documentation including: 
1. Hazard Analysis and Risk Assessment (HARA) reports 
2. Functional and Technical Safety Requirements 
3. Safety Plans and Safety Case documentation 
4. Software and Hardware Safety Validation and Verification reports 
5. Traceability matrices ensuring compliance from safety goals to implementation and tests 
6. Tool qualification and configuration management records 
7. Evidence of adherence to standards such as ISO 26262, DO-178C, or IEC 61508 
 
Gap Analysis and Compliance Checking: 

1. Identify inconsistencies, incomplete information, or deviations from safety standards and recommend corrective actions. 
2. Validate that the safety lifecycle activities have been appropriately executed. 
 
Audit Support: 
1. Prepare and organize safety artifacts for internal and external audits. 
2. Provide subject matter expertise during audits by: 
 – Clarifying safety processes and evidence to auditors 
 – Demonstrating compliance with relevant standards and project requirements 
 – Addressing auditor queries and facilitating resolution of non-conformities 
 
Continuous Improvement: 
Propose improvements to safety processes and documentation practices based on audit findings and lessons learned to enhance future compliance and efficiency. 
 
Cross-Functional Collaboration: 
Work closely with system engineers, software developers, quality assurance teams, and project management to ensure alignment on safety objectives and timely resolution of safety issues.

1. Definition of Tool Use Case

2. Tool Classification
Determine:
Tool Impact (TI): Can a failure in the tool lead to an error in the safety-related item?
Tool Error Detection (TD): Can the tool’s output errors be detected by subsequent activities?

3. Tool Qualification Strategy
Select one of the appropriate qualification method(s)  or combination based on the TCL:

• Increased confidence from use
• Evaluation of development process
• Validation of tool functionality

4. Tool Qualification Plan

5. Execution and Evidence Collection

6. Tool Qualification Report

Training is offered as a foundation of a strong safety culture: 

1. Automotive FuSa with ISO26262  

Course Overview: 
This course provides a structured introduction to automotive functional safety based on the international standard ISO 26262. It covers the complete safety lifecycle, including risk assessment, safety requirements, architecture, implementation, and validation of safety-critical systems in automotive applications. 

Course Objectives: 
. Understand the purpose and structure of ISO 26262 
. Learn how to apply the safety lifecycle to real-world automotive projects 
. Identify safety goals, perform hazard analysis and risk assessment (HARA) 
. Develop and manage functional and technical safety requirements 
. Gain insights into ASIL levels, safety mechanisms, and confirmation measures 
. Apply safety principles across system, hardware, and software development 

Key Topics: 
. Introduction to Functional Safety and the Automotive Safety Lifecycle 
. Structure and Scope of ISO 26262 (Parts 1–12) 
. Hazard Analysis and Risk Assessment (HARA) 
. ASIL Determination and Decomposition 
. Functional and Technical Safety Concepts 
. System, Hardware, and Software Safety Requirements 
. Software Development under ISO 26262 (ASIL A–D) 
. Verification, Validation, and Safety Analysis (e.g., FMEA, FTA, FMEDA) 
. Tool Qualification and Confidence in Use 
. Safety Case and Assessment Preparation 

 
2. Engineering of Reliable Embedded Systems 

Course Overview: 
This course, derived from the foundational principles in “Engineering a Reliable Embedded System”, equips participants with the skills to design, develop, and maintain dependable embedded systems for safety- and mission-critical applications. Emphasis is placed on predictability, testability, maintainability, and robustness in C-based embedded systems, without relying on complex operating systems or dynamic memory. 

Course Objectives: 
. Understand what makes embedded systems reliable and predictable 
. Learn how to design systems with long-term operational dependability 
. Apply real-world techniques to avoid common sources of failure 
.Gain hands-on experience with proven architectural patterns and design principles 

Key Topics: 
. Introduction to reliability in embedded systems 
. Designing predictable systems without RTOS 
. Time-triggered (TT) architecture and cooperative scheduling 
. Safe scheduling using cyclic executives 
. Watchdog timers, system startup, and shutdown 
. Exception handling and system reset strategies 
. Design for testability and maintainability 
. Long-term reliability strategies (e.g., EEPROM wear management, redundancy) 
. Practical C coding guidelines for reliable systems 
. Case studies and real-world implementation patterns