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)
  • Risk assessment (ISO 14971, ISO 14121)
  • Usability engineering (IEC 60601-1-6)
This includes making the technical file and doing the corresponding checklists.
EMAIL US
CALL US
Home2020-02-06T08:31:05+00:00

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.

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.

Read more

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

Read more