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)

  • Usability engineering (IEC 60601-1-6)

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

Why choose Eldotek?

Here at Eldotek we have confidence, and with more than 20 years of experience in the field, we believe that the recipe to the best result, and for you to get a CE marking is through open dialogue and teamwork.

Eldotek has specialised in making safety Critical devices CE compliant and under this, we’ll cover areas such as:

  • Professionel test of products

  • Structured Development process

  • Risk assesment

  • Software development

  • Usability engineering

Interested in hearing more?
You can contact us through mail, info@eldotek.dk, phone +45 28 20 20 14 or fill out a format here.

Professional test of products

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

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.

Risk Analysis

Risk analysis is an essential input to the product, i.e. to foresee user risks by

  • Define user safety
  • Conduct user risk analysis
  • Include risk mitigations in product requirements

 


BÅSTRUPVEJ 218
3480 FREDENSBORG
Google Maps

+45 2820 2014

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.

www.konsulent-klyngen.dk