Transitioning to EU MDR and IVDR would require coping up with a lot of evolving regulatory requirements and the only way to identify and apply these added requirements is to have a strategy in place. Regulatory strategy is a plan of action designed to achieve a specific regulatory goal to obtain approval of your Medical devices and IVD devices. A solid regulatory strategy and execution can maximize the opportunity to achieve the regulatory goal by complying with the requirements of MDR, IVDR and ISO 13485 and provide a competitive advantage.
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