Accuracy and precision are crucial factors that must be considered when developing any medical device. Medical devices today typically consist of multiple parts and dimensions. In addition, these products are produced in large quantities. It is up to the accuracy of the machines and processes that create these parts to remain both accurate to the drawings, and consistent. Without accuracy, companies begin to produce products that were not initially intended to be created and as a result presents risks to the consumers. In addition, without precision, some products may be accurate, and some may not. This lack in consistency presents risks to some consumers. For these reasons, the FDA finds the accuracy and precision of all medical devices to be particularly important. Because no single machine or process is 100% accurate or precise, marginal errors must be determined so that there is a range of specifications that must be met in order to be considered acceptable. From my experience working in the industry, I’ve noticed a great amount of time and effort has been put into producing test samples of every aspect of every product to be measured and tested. Elaborate statistical analyses are then made with the data extracted from these samples in order to determine if what we are producing is acceptable. On top of that, both hardware and software that are used in the development of these products must also be tested in order to ensure the prolonged accuracy and consistency of the items created.