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The Quality Management System (QMS) is vital to any medical device company. It is not only a regulatory requirement but it sets the framework for how a device is designed, developed, manufactured and distributed. It also ensures that customer feedback, including complaints are captured and fed back into the system resulting in continual product improvement. When setting up a QMS it's important to know your business, consider current trends in your industry and develop a process that is efficient and adaptable. The regulations require that you have a QMS. It's up to you to design a QMS that works for your business.
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