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 products has to have all upstream sub-processes under control.
Having them under control means not only that all of these individual processes run harmoniously from a technical perspective (so-called quality of content), but rather that all individual process are documented and validated in all of their indivudal steps as well (so-called formal quality).
As an end-product manufacturer and market supplier of these products (pusuant to EU derective 93/42), Bürki has all of this information – not only with respect to its own internal processes, but with respects to its suppliers as well.