Industry 4.0 changes the world of automation. Co-bots, AI and predictive maintenance drive a paradigm shift in automation. Machinery is interacting with human operators, maintenance staff or even the public, forming safety-critical interfaces – the reliability of safety features is paramount in all those use cases. Additionally, sensible company data or the production ability itself can be attacked via IOT features or production management systems, raising the importance of production security.


The EC machine regulation from 2006 will be replaced soon by a new machinery directive putting more emphasize on electronic controls and inherent security risk. Be prepared and do not hesitate to contact us for more info on upcoming new regulations.

We certify and approve your solution for industrial automation and safety protection.

We look at your network and cyber security process to identfy threats before hackers do.

EC Type Approval and CE Conformity

Do you have a safety-critical machine? It needs an electronic control to maintain safety? In order to comply with the CE directive and, more specifically with the EU machinery directive EC 2006/42 CertX may provide such EC type approvals as notified body NB 2948 listed in the EU NANDO register.


We evaluate the safety risks for electronic controls according to the EU machinery directive EU 2006/42 and related harmonized standards such as EN ISO 13849, EN IEC 62061, EN IEC 61496, EN ISO 61800 or others.


We are also verifying the security of your industrial networks and equipment. Be more secure against cyber threats, misuse, and black mails it will become mandatory soon with the new machine regulation.


The CE marking requires adherence to applicable standards and regulations. For dangerous machines according to annex IV of the EC 2006/42 machine directive for

  • protective devices designed to detect the presence of persons.
  • logic units to ensure safety functions.

CertX can provide the required EC type approval which enables you to complete the CE declaration, learn more about the process here.

CertX may also support you in identifying the required standards to comply with beyond the functional safety and security standards and verify your risk assessment according to EN/ISO 12100.

Training & Person Certification

CertX provides a dedicated person certification program at different level of expertise for responsibilities for safety management related to ISO/IEC 61508 and 13849.


CertX experts can also provide customized and in-house training to meet the your needs for qualifying your staff.


    Product Inspection & Certification for Functional Safety

    Our services verify the compliance of your product with the functional safety standards e.g. an integration into a machine or safety-related equipment. You will be able to demonstrate to your clients the compliance against IEC 61508, EN ISO 62061, EN ISO 13849 or other standards without disclosing any IP. Our detailed compliance feedback will help you to improve your product and minimize product liability risks.


    CertX provides independent assessment according to the different parts of the standard depending on the needs of your project.


    Functional Safety Management:

    • Management system
    • Policy
    • Functional safety planning
    • Configuration Management
    • Organization and competencies
    • Life-cycle planning
    • Documentation
    • Conformance plan
    • Supplier management



    • Hazard and risk analysis (risk graph, layer of protections,…)
    • Review of overall system specification & safety requirements
    • Product identification & specification
    • Mission profile evaluation



    • Failure rates & Diagnostics
    • Safe-failure fraction & Hardware fault tolerance
    • Data communication
    • Maintenance
    • Measures for systematic fault avoidance



    • Safety & integrity function requirements
    • Requirement traceability
    • Safety functions and diagnostics
    • Testability and tests
    • Data communication
    • Proven in use arguments
    • Supporting tools
    • Module & integration testing
    • Impact analysis
    • Validation


    Learn more about our product assessments or about our certification process

    Cyber Security services for industrial systems and OT Security management

    Security is becoming a priority in industrial IT and Operational Technology (OT) as connectivity to external networks grows and attacks on operational technology increase. Many companies are still not aware of the threats that cyberattacks pose to their OT assets. Moreover, their measures for cybersecurity are usually not tailored to operational technology


    New EU/UN directives (e.g. NIS, RED) and national rules are also nowadays considering cyber security of industrial infrastructure and their systems as a major pillar for safe operations, at any point of the supply chain. In that context, ISA/IEC 62443 standard series represent the State-of-the-Art

    CertX Cyber Security team supports industrial actors based on following services:

    • Awareness & Education
      • Increasing awareness and understanding about best IT/OT security practices throughout introduction courses, or deep-dive sessions on specific methods, e.g. cyber threat analysis and risk assessment
    • Compliance check & certifications for evaluating your current management system practices, processes and product capabilities, and validate them according to ISA/IEC 62443, ISO/IEC 15408 (Common Criteria), or any other related reference document.
    • Technical evaluation & Testing for challenging your products and/or infrastructure against attack attempts
    • Supporting services for accompanying your team on the right path for implementing best security practices and complying with State-of-the-Art references.

    Feel free to contact our Cyber Security team for more info


    Andreas Gruber

    Head of Functional Safety
    T +41 26 309 29 95