In 1983, the Nordic countries took the first steps towards standardising the quality assurance system for sterile single‐use medical devices. Today, the Nordic authorities have…
Abstract
In 1983, the Nordic countries took the first steps towards standardising the quality assurance system for sterile single‐use medical devices. Today, the Nordic authorities have agreed on the same quality assurance procedures for these products and the system is expanding to other groups of medical devices. The approach taken to assure the quality of medical devices is described and the value of standardisation, the use of pre‐market regulations and post‐market control is discussed, together with the concept of good manufacturing practice (GMP).