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  • Luisa Gutierrez replied to the topic No GMPs in the forum Quality Systems Management 8 years ago

    That is great input to this discussion so far. To add to the idea, the GMP is definitely required to also ensure that the product being sold is consistent. If the documentation used to make the product didn’t provide the necessary instructions and details, it may cause the production working to make a device with drastically different dimensions. In addition, due to the lack of specificity of the product, it may lead to other issues such as mislabeling. For example, if a patient is in surgery and the surgeon picked up a medical device based on the size that would fit the patient. If the label is incorrect, then the surgeon is giving the patient a device that would not work to the best of the ability and would not fully benefit the patient. Lastly, tying that idea to what was explained above, the customers for the products will make sure that the device is high quality with GMP regulated to prevent any further issues.