ABSTRACT
Quality systems is the first key factor to be examined in an attempt to assess the place that such systems should occupy in a modern medical device regulation.
Until well after the Second World War, most manufacturing industries tried to ensure that they sold only satisfactory products on the basis of inspecting finished products, identifying defective units and scrapping or reworking them. This defensive technique has generally been abandoned in favour of controlling the production process (Bergman and Klefsjo 1994).
