We want to provide our customers with products and services which:

  • meet the customer expectations;

  • comply with the quality and regulatory requirements conform the intended use statement appropriate for the purposes for which they are developed, manufactured and distributed;

  • are effective, safe and reliable (risks are identified, minimized and controlled during the whole product life cycle).

We want to promote within the complete organization the objective of quality focus and maintenance of the quality system effectiveness.

Therefore, all processes involved in the life of our products, from concept through design, manufacturing, distribution, installation and servicing follow the ISO 13485 quality management system for medical devices.

Our facility in Zwijnaarde is compliant with the local requirements of the countries where we distribute products (cGMP,…) and ISO 140001 certified.

Fujirebio Europe in vitro diagnostic kits are CE marked and meet all necessary requirements.

Fujirebio - IVD quality system

Quality resources that you might be looking for:

Our local quality policies:

A brief video introduction to our Fujirebio Europe site in Gent, Belgium, and to our quality system: