Functional safety.

Our expertise in functional safety.

We are a leading development service provider for functionally safe devices in measurement, control, regulation and drive technology, medical technology, for associated operating devices and for components of collaborative robot systems. We combine many years of development experience with efficient processes to ensure your success.

In embeX, you will find an excellent partner for all questions relating to functional safety: embeX was the first company worldwide to be awarded the highest Maturity Level (5) for functional safety management (FSM) in accordance with IEC 61508 by TÜV Rheinland.

Our employees actively contribute to safety standards such as IEC 61508 (SIL) and are in constant contact with all renowned accredited testing centres.

Your advantages with embeX.

  • Functionally safe devices from a single source
  • Experience from more than 150 successfully completed functional safety development projects
  • Cost- and time-optimised development through the use of customised development processes during development
  • High certification success through highest maturity level of development processes

Development services.

  • Competent and comprehensive advice during the design phase
  • Definition and implementation of a lean development process for safety-related products
  • Specification of safety requirements
  • Development of security concepts
  • Development of a functionally safe hardware architecture
  • Development of functionally safe self-test libraries (STL) for ARM®-based controllers up to SIL 3
  • Standard-compliant verification and validation
  • Risk and failure analyses (FMEA, FMEDA, FTA) from the system to the component level
  • Calculation of safety indicators such as PFH, PFD, SFF, MTTFd
  • Design and sizing of safety-related mechanical components
  • Approval and certifications: Preparation of documents and representation before the examination authority

Technologies.

  • Safety concepts

    We offer comprehensive safety concepts for your projects, taking potential hardware failures into account and selecting suitable hardware architectures. Our expertise includes the qualification of sensor technologies for safety applications and the safe handling of non-safe software components such as SOUP, COTS and legacy software. We also design the safe operation and parameterisation of your systems.

  • Functionally safe hardware architecture

    Our functionally safe hardware architectures cover a wide range of security requirements: From single-fault safety according to category 2 of ISO 13849 and HFT 0 according to IEC 61508 to double-fault safety according to categories 3 and 4 and HFT 1. In addition, we develop fail-safe solutions in accordance with EN 60601-1. We carry out risk and failure analyses, such as FMEA, FMEDA and FTA, from the system level down to the component level.

  • Functionally safe software

    In functionally safe software, we develop self-test libraries (STL) for ARM®-based controllers up to SIL 3 High Demand. Our certified libraries, including the self-test library distributed via microchip, are available. Further developments are possible on request.

  • Safety and security

    In addition to safety, we also take security requirements into account. In accordance with IEC 61508-1 and IEC TR 63074, we conduct vulnerability analyses for foreseeable threats to IT security in order to define IT security requirements. We support our customers in all matters relating to cybersecurity and ensuring safety through security.

  • Functionally safe drive systems

    For functionally safe drive systems, we develop Safe Motion solutions with safety functions such as STO, SBC, SS1, SLP, SLS and SLT. Our systems also enable active movement to safe positions with energy storage devices and support components of collaborative robot systems.

  • Functionally secure communication

    We offer integration of the following secure interfaces: CANopen Safety, CIP Safety, OPC UA Safety, FSoE, IO-Link Safety, open Safety, PROFIsafe, Safety over APL.

Guidelines & standards.

We are certified to IEC 61508 and work in accordance with the following directives and standards, among others:

  • IEC 61508 Functional safety of electrical/electronic/programmable electronic safety-related systems
  • IEC 62443 Security for industrial automation and control systems
  • IEC TR 63069 Industrial-process measurement, control and automation – Framework for functional safety and cybersecurity
  • IEC TS 63074 Safety of machinery — Safety aspects related to functional safety of safety-related control systems
  • Bundesamt für Sicherheit in der Informationstechnologie (BSI):Cybersecurity-Anforderungen für vernetzte Medizinprodukte
  • Guidances der FDA: „Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”
  • Guidances der FDA: „Postmarket Management of Cybersecurity in Medical Devices”
  • CLC/TS 50701 Railway applications - Cybersecurity

Start your project with embeX.