Eldotek has specialised in making
safety Critical devices CE compliant
with focus on:

  • Medical Device Directive 2007/47/EC (IEC 60601)
  • Machine Directive 2006/42/EC (IEC 61508)
  • with special attention on the new issues of:

  • Risk assessment (ISO 14971, ISO 14121)
  • Software development (IEC 62304, IEC 61508-3)
  • Usability engineering (IEC 60601-1-6)

This includes making the technical file and doing the corresponding checklists.



Eldotek cooperates with Konsulent-Klyngen specialising in electronics construction including embedded software.


test of products

development process