Emdesar offers consulting and coaching services in the field of safety-critical systems.
The strength of Emdesar is the broad experience from different areas, which enables applying best practices across domain boundaries.
Many years of experience with working in a regulated environment.
Familiar with many standards related to Functional Safety, as well as Cyber Security (OT).
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Embedded Architectures
A solid architecture pays off over the lifecycle
A good architecture not only saves product development costs, but it is a prerequisite for efficient maintainability. When it comes to safety-critical systems, the architctures is even more important because it largely determines whether you will be able to meet the project goals in terms of reliability, availablity, maintenance and safety/security (RAMS).
Services
- ✔ Elaboration of risk-based HW/SW architectures in general or to a specific standard, e.g. single-fault-safety for Medical Devices acc. to IEC 60601-1
- ✔ Elaboration of architectural concepts
- ✔ Review / Assessments of HW/SW architectures
- ✔ Failure Analysis of HW/SW designs
- ✔ Refactoring of a HW/SW architecture design (after a previous analysis)
- ✔ Implementing of error prevention and failure management methods
Product Development
First time right
No mater which development method (agile, V-model, etc.) you use, the most efficient way to bring a product to market, is to avoid costly mistakes. That's where experience comes into play!
Services
- ✔ Supporting / coaching multidisciplinary product development teams in following a specific process, e.g. for Medical Devices
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Supporting multidisciplinary product development teams in various roles:
- Technical Project Management
- System or HW/SW Architect
- System or Integration Engineer
- Safety Engineer
- Risk Manager
- Independent Reviewer or Coach
- etc.
Process Elaboration
The process should serve the project, and not vice-versa
A product development can only advance efficiently, if suitable processes are in place. Fixing issues with the process not only boost efficiency in the long run, it also improves motivation of the team. Not to mention, that Plan-Do-Check-Act requires continuous improvement in many SOPs anyway.
Services
- ✔ Elaboration of work procedures to follow a certain process or standard (e.g. for writing SW acc. to IEC 62304)
- ✔ Tailoring the application of a process to the specific needs of a product development team and its environment
- ✔ Negociating the application of an SOP between the development team and QA/RA
- ✔ Enhancing exisiting processes with new requirements (e.g. IEC 623304 with cybersecurity acc. to IEC 81001-5-1)
- ✔ Tailoring the application of a process to the specific needs of a product development
- ✔ Improving quality assurance to meet a certain standard (e.g. implementation of IEC/TR 80002-1 in Medical Devices)