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Welcome to Beebrox projects!
Beebrox Quality Policy!
The quality of our products and services is always in accordance with the requirements, needs and expectations of our customers but mostly in accordance and ruled by with domestic and foreign regulations.
The organization's priority is to meet the requirements of the quality management system in the manufacture of medical devices according to ISO 13485:2016 MDR, IVDR or FDA requirements.
Requirements management is key for our success, scoping and quantify objectives early on.
We provide key industry intelligence for R&D and product preclinical validation know-how to comply with the state of the art in targeted areas and serve clients to reach their quality objective through our commitment and share accumulated experience in regulatory, quality, and technical R&D support. Through extensive research activities and reviewing of science-based position papers and valid regulatory material.
We offer services aligned with the MDR regulative and recognized and harmonized technical standards. We track field of standards closely, and if needed before they are released.
The quality of products and services is assured and maintained through all stages of the business process, set up and maintained in an organized manner within the quality system.
We strive for excellence to exceed customer expectations by offering them top down - holistic regulatory/quality and combine it from bottom up - technical - R&D intelligence providing clients what they lack in time.
Most importantly we assure we provide information in such manner, making management decision of client a transparent and easy to follow risk-based processes."
Bostjan Barbis, CEO
Beebrox project serves us with the following!
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Projects
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