This has now been superseded by ISO 13485:2016, which came out on March 1, 2016. The first update to ISO 13485 was released in 2003. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first edition was published by the International Organization for Standardization (ISO) in 1996. The international standard ISO 13485 governs the manufacture of medical devices. By Michael Kanis, National Sales Manager, Proven Process Medical Devices
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