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.


CertX is a notified body NB 2948 listed in NANDO register. We evaluate the safety and security risks according the EU machinery directive EU 2006/42 and related standards such as EN/IEC 61508, EN/ISO 13849, EN/IEC 62061 for safety and IEC 62443 for security through a comprehensive certification and inspection program.

CertX, your key partner for supporting you in all functional safety topics

EC Type Approval for Machine Directive and CE Conformity

You have a safety critical machine? It needs an electronic control to maintain safety? In order to comply with the CE directive and more specific with the EU machinery directive EC 2006/42 we perform type examinations and provide EC type approvals in case of compliance.


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.


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.

Product Inspection & Certification for

ISO/IEC 61508 / 13849 / 61496 / 62061

Our services verfiy the compliance of your product with the related standard(s) for e.g. an integration into a machine or saftey related equipment.  You will be able to demonstrate to your clients the compliance with safety standards without disclosing any IP. Internally you may use our detailed inspection or compliance checklist to improve your product and minize 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 assessment:

  • Management system
  • Policy
  • Organization and competencies
  • Life-cycle
  • Documentation
  • Conformance plan
  • Internal procedures
  • Supplier management

System assessment:

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

Hardware assessment:

  • Functional safety planning
  • Lifecycle requirements
  • Failure rates & Diagnostics
  • Safe-failure fraction & Hardware fault tolerance
  • Data communication
  • Maintenance
  • Measures for systematic fault avoidance
  • Validation records

Software assessment :

  • Functional safety planning
  • Configuration management
  • Lifecycle requirements
  • 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

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.



    Andreas Gruber

    Head of Functional Safety
    T +41 26 309 29 95