In today’s rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in managing compliance and bringing their products to market efficiently. As a regulatory professional, you’re likely all too familiar with the time-consuming and intricate process of preparing regulatory submissions. The use of AI streamlines this process to reduce errors, improve compliance and get your product to market faster.
The new article highlights the aspects related to the costs associated with establishment licenses, and supporting documentation interested parties should submit, and also explains cooperation between different regulating authorities and bodies.
The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.
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