•The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
•Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
•For medicinal products the risk management documents/plan is achieved by
•If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
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