Projects
Contact for Premium Business Services
Our project portfolio spans a diverse range of industries, including medical devices, railway, automotive, and aerospace. Across these domains, we engage in a variety of activities such as safety management, concept development, safety analysis, process analysis, and process improvement. This breadth of expertise underscores our commitment to delivering comprehensive, industry-specific solutions that enhance safety, innovation, and operational efficiency. Below are some examples.
Safety Concept Development for an Electric Car
“Our specialists contributed to the development of a safety concept for an electric car, with a focus on powertrain control and high-voltage safety. The safety concept was developed in accordance with ISO 26262 and encompassed comprehensive work packages, including Hazard Analysis and Risk Assessment, Functional and Technical Safety Concepts, Architecture and Design, Test and Integration Strategy. Additionally, detailed safety analyses such as FMEDA (Failure Modes, Effects, and Diagnostic Analysis) and FTA (Fault Tree Analysis) were conducted to ensure rigorous adherence to safety standards.”
Gap Analysis and Quick Wins concept
FuSaExperts conducted a Gap Analysis for a company specializing in mechanical and electrical design. The rise of Software Defined Vehicles offered new project opportunities, but the company faced challenges due to a lack of expertise in safety and software.
Our specialists visited the site, interviewing key teams and using a modular approach to assess gaps against ISO 26262 and Automotive SPICE standards. We delivered a detailed report with practical quick-win recommendations, including:
– Establishing formal documentation for efficient impact analysis.
– Organizing System Engineering teams for better coordination.
– Improving supplier management with Development Interface Agreements (DIAs).
– Automating safety analysis for streamlined operations.
– Enhancing change and requirements management.
– Defining robust integration and test strategies.
FuSaExperts also supported the company in planning and navigating the certification process, aligning with standards and ensuring compliance. This tailored support helped them bridge gaps, achieve certification, and seize opportunities in the Software Defined Vehicle market.
Medical Device Safety
Essential terms like Essential Performance, Single Fault Safety, and Human Factors are integral to medical device standards such as ISO 60601, ISO 62304, Medical Device Regulation, and Risk Management. FuSaExperts contributed to the development of critical systems, including lung ventilators and glucose monitoring devices. Our work encompassed creating Safety Concepts, maintaining Risk Registers, conducting Safety Analyses, collaborating with Notified Bodies, and preparing documentation for regulatory submissions. This expertise ensured compliance with industry standards and facilitated successful device approvals