Today, the production of an item used in healthcare is an overall process, which is comprised of a whole network of individual processes with internal and external players. Whoever is responsible for the overall or final product has to have all upstream sub-processes under close control.
Having all of these intricate processes under control means not only that all of these individual processes run harmoniously from a technical perspective (so-called quality of content), but also that all individual processes are documented and validated in all of their individual steps as well (so-called formal quality).
As an end-product manufacturer and market supplier of these products (compliant to EU Regulation MDR 2017/745 EN), Bürki has all of this properly documented – not only regarding our own internal processes, but regarding our suppliers as well.