Functional Safety

Safety critical systems need to meet stringent requirements set by standards and regulators. We can help you meet these requirements cost effectively.

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Huld helped EKE-Electronics expand into new markets

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Functional Safety Services

We have long experience in developing safety and mission critical systems. Our services are based on proven concepts that have been used from product conceptualization all the way to product certification.

We support our clients in all aspects concerning functional reliability of safety critical systems. Our services cover everything from concept development to product validation. Sometimes our clients will assess their own readiness to develop safety critical products. We help and support our clients also in these aspects.

The first step in developing a safety critical product, which meets functional safety standards such as the IEC 61508, is to develop a high-level solution called the functional safety concept. The functional safety concept defines the key safety requirements, the high-level hardware and software architecture and the diagnostics approach.

Our team can take full responsibility of developing a safety concept for your system. We have extensive experience of standards such as IEC 61508, EN ISO 13849 and ISO 26262. The concept development will follow our standardized approach, which ensures that the end result will be a compliant safety concept that also meets your other requirements.

Where we are good at:

Functional Safety Concept: creating or refining the Functional Safety Concept based on the customer requirements and Risk Assessment results, defining the required SILs
Technical Safety Concept: creating System / HW / SW architectures, deriving detailed requirements for HW, SW and diagnostics in order to meet the required SILs
IEC 61508, EN ISO 13849 and ISO 26262

We give you the confidence in your product’s safety and certification by helping you plan the necessary Functional Safety activities for the entire product development lifecycle. All of our safety specialists are TÜV Süd certified Functional Safety Professionals. We bring you the competencies you need to prepare the required Safety Documentation and conduct.

Where we are good at:

Hazard Analysis and Risk Assessment: PHA, OHA, FFA, FHA, HazOp, HAZID, etc.
HW / SW / System FMEA, FMECA, FMEDA
Fault Tree Analysis
HW Reliability Analysis
Usability and Human Factors analysis (heuristics, task-based analysis, etc.)
SW / HW / System Safety Analysis, Safety Case, SIL verification analysis

Our safety team conducts safety assessments in technology fields where functional safety plays a role: for example, automotive industry, nuclear industry, railway industry and medical industry. The purpose of Functional Safety Assessments is twofold: to ensure that all the activities and documentation for the particular Safety Lifecycle phase have been completed as per requirements (presenting a safety case), and to help prevent systematic failures from being introduced. Examples of relevant standards, against which functional safety assessments are conducted are ISO 26262, IEC 61508, EN 5012X.

In addition to Independent Safety Assessments (ISA), we also do other assessments and gap analyses to support our clients in the following sectors:

general industry where IEC61508 is applicable
nuclear (regulatory guides and standards: YVL, IEC 61513 / 60880 / 62138 / 60987 / 60780),
machinery (regulatory directives and standards: ISO 13849),
medical (regulatory directives and standards: Medical Device Directive 93/42/EEC, Directive 80/181/EEC, ISO 14971, ISO 13485, IEC 62304, EN IEC 62366-1, IEC 60601-1, EN 1041),
automotive (regulatory directives and standards: ISO 26262, Automotive SPICE)
tractors and machinery for agriculture and forestry (regulatory directives and standards: ISO25119)

Where we are good at:

helping you to reduce your safety and certification risks, to increase the technical quality and to extend the lifetime & value of your product
gap analysis vis-à-vis functional safety standards (IEC 61508, ISO 26262, ISO 61511, etc.)
system failure mode and risk analysis
design assessment
code analysis
Verification & Validation assessment

Taking on a safety critical development project is challenging for the first time. The risk of overengineering or missing important aspects is significant. We have years of experience of developing mission and safety critical systems, making us a reliable partner for safety critical projects.

Our safety team can take full or partial responsibility of the project. Our services include:

Safety management
Safety analysis
Full V&V responsibility

Where we are good at:

safety-critical software development and V&V for embedded systems: from a safety concept to a certified product
across all safety- and mission-critical industries:
- Machinery
- Aerospace
- Railway
- Automotive
- Medical devices
- Nuclear

Huld has been accredited by FINAS to be a type C Independent Safety Assessor (ISA) inspection body, accreditation number I051. Specifically, we can perform standard based safety assessments for Railway control, command and signalling subsystem (CCS) and Rolling Stock subsystem (RST). The standards in the scope of assessments include EN 50126, EN 50128, EN 50129, EN 50159, IEC 61508 and CSM ISA also known as AsBo. The SFS-EN ISO/IEC 17020:2012 standard is the accreditation requirement for inspection bodies.

Where we are good at:

independent standard-based safety assessments for railway control, command and signalling subsystem (CCS) and rolling stock subsystem (RST)
EN 50126, EN 50128, EN 50129, EN 50159, IEC 61508, CSM ISA