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.

Konsulent Klyngen

Konsulent-klyngen

Eldotek cooperates with Konsulent-Klyngen, specialising in electronics construction including embedded software.
Konsulent-klyngen covers a group of experienced and talented people. They’ve had succes with operating for more than 30 years, always delivering impeccable solutions for a variety of tasks.

 

Professional
test of products

Professional test of products

We realise the importance of a thoroughly tested product, and we do that through more than 20 years of experience.

ISTQB Testing
Risk analysis: “foresee user risks”
Functional safety software

With a variety of competences with both risk assesment, software development and usability engineering, we’re able to offer you the best result and the best price.

Structured
development process

Structured development process

We can with confidence give the correct counseling.
This is a speciality from Eldotek, where we cover areas such as:

CE Marking
Risk management and verification
Requirement specification and management with UML, agile methods

For us structure is important and a key factor to succes.