How to Address 10 Common Pains in Dossier Management & Product Registration

While the process for obtaining a device clearance or premarket approval (PMA) in the United States is not the same as applying for a Shonin in Japan or a CE mark in Europe, there are many similarities, especially when it comes to dossier management pains and challenges. The pains are worse for companies using a paper-based or hybrid (part electronic and part paper) system.

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