Reliable long-standing quality system

We never compromise on quality and safety.

The objective of Blue Medical is to supply products and services of uncompromising quality by complying with the regulatory requirements of ISO 13485:2016 and adhering to strict quality assurance principles.

Patient safety is the highest priority

We will remain consistent in our commitment to fair and truthful producing practices, never compromising on the safety and quality of our products, upon which our own success and the success of our customers ultimately rest.

Cleanroom (class ISO 7)

Primary packaging takes place in our clean room (class ISO 7) with qualified and constantly monitored equipment. Our qualified staff ensures full traceability of the products during the entire process.

Cleanroom (class ISO 8)

Assembly and final packaging (class ISO 8) Finished primary packaged medical devices are then assembled into final package (e.g. with instructions for use, patient labels, etc.). The finished packs are then palletized in sterile boxes according to the loading plan, protected for transport and sent for sterilization.

Certified by EN ISO 13485:2016
Quality management for medical devices