Gap analysis
Identify technical, process and evidence gaps and receive a prioritized improvement plan.
The established foundation
Safety engineering grounded in real development programs.
Practical support from early concepts and safety planning through detailed analysis, verification and certification-ready evidence.
Delivered to customers: Safety for Dynamic Development Teams - a phased route from a focused gap analysis and immediate quick wins to a scalable safety process, compliant work products and long-term internal capability.
Our way of working
Safety for Dynamic Development Teams
Traditional safety approaches often assume mature organizations, stable architectures and established development processes. Fast-moving teams need to make safety decisions earlier.
We use optimized safety processes for startups, scale-ups, innovation units and new programs inside established organizations. Analyses can begin conservatively and gain detail as architecture, data and evidence mature.
- 01Start conservatively
Use explicit worst-case assumptions where system detail is still missing.
- 02Transfer critical information
Bring safety-relevant findings rapidly to architecture and development teams.
- 03Make focused decisions
Resolve the safety questions that matter for the next development milestone.
- 04Refine the analyses
Enrich models and revisit assumptions as architecture and data mature.
- 05Build mature evidence
Maintain consistent analyses, traceability and reviewable safety arguments.
Assumptions remain explicit and reviewable. Each phase has defined inputs, outputs and review points, so teams can act on safety-critical information without waiting for every detail to be settled.
Delivered to customers: safety management and planning, hazard and risk analysis, functional and technical safety concepts, requirements, architecture, FTA, FMEA, FMEDA, verification, safety cases, gap analysis and practical capability building.
Ways to engage
Start at the level the program needs.
The scope can be a focused decision, a defined engineering delivery or integrated support across the lifecycle.
Engineering in practice
From architecture to measurable evidence.
Safety decisions are developed alongside the real product architecture, interfaces, failure behaviour and verification strategy.
Core services
Build safety into the engineering work.
We support complete programs or focused work packages, working alongside engineering teams, suppliers and management.
Plan and manage
- Safety management and Safety Plan
- Development Interface Agreements
- Supplier coordination
- Assessment preparation
Analyze and define
- Hazard analysis and risk assessment
- Safety Goals
- Functional Safety Concept and Functional Safety Requirements (FSC / FSR)
- Technical Safety Concept and Technical Safety Requirements (TSC / TSR)
- System, hardware and software safety requirements (HW / SW)
- Safety architecture and design
Verify and demonstrate
- FTA, FMEA and FMEDA
- Verification, validation and test strategy
- Safety cases
- Certification-ready documentation
Improve the organization
- Gap analysis and practical quick wins
- Process analysis and improvement
- Change and requirements management
- Tool and environment evaluation
Develop capability
- Role-based training
- Coaching inside live programs
- Review preparation
- Lessons from real projects
Work across the lifecycle
From concept and architecture through detailed development, integration, evidence and assessment readiness.
Frameworks
Standards translated into engineering decisions.
Our work draws on the relevant framework and product context without reducing safety to a checklist.
ISO 26262
ISO 21448
IEC 61508
ISO 14971
IEC 60601
IEC 62304
EU MDR
FDA expectations
Support, not certification authority
FuSaExperts prepares engineering work products, evidence and organizations for reviews, regulatory submissions and assessments. The responsible approval and certification bodies retain their formal roles.
Sectors
Cross-sector experience, context-specific execution.
The safety principles connect. The hazards, architectures, lifecycle constraints and regulatory expectations differ.
Automotive
ADAS and automated driving, electric powertrains, high-voltage systems, vehicle dynamics and control systems.
Medical devices
Risk management, essential performance, single-fault safety, software safety and regulatory documentation.
Railway
Integrity-critical system development, safety management, concepts and structured assurance evidence.
Industrial systems
Functional safety for machinery, control and process environments with practical organizational integration.
Need focused support or a complete work package?
We work with large organizations and agile start-ups, adapting to the maturity and pace of the program.