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Showing posts with the label EU MDR GAP analysis

3 Reasons Why Medical Device Regulation Is Important

  Nowadays, nearly every country has certain set standards when it comes to medical device manufacturing. These regulatory bodies are tasked with the responsibility of ensuring that any new medical device has been properly tested and shown to meet the required standards before being released into the market. Here are 3 reasons why medical device regulation is so important: Ensures safety for patients Medical devices are used in the diagnosis and treatment of various conditions. For this reason, any defect in such a device can lead to poor health outcomes for patients. Hence, it is extremely important to have comprehensive EU MDR GAP analysis to ascertain quality and efficiency of any device before it is released to the market. Encourages excellence and innovation The stringent measures put in place by medical device regulation bodies help to propel manufacturers towards achieving excellence. Innovation and creativity is needed to achieve the high standards se...