Iso 13485 design control11/3/2023 This precisely is already the essence of design controls – a proof that a medical device is designed safely and effectively, meeting the necessary requirements. Only then it can be placed on the market. Therefore, all the regulatory bodies, such as the FDA, European Commission and others demand an assurance that the manufactured medical device is safe according to pre-set standards and fulfils its intended purpose. However, it is the most essential trait above all in the whole story of medical devices that the devices are designed and developed safely. The journey of a medical device, from its idea to its final use, can appear to be quite long.
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