• 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) To Continue reading : https://bit.ly/3e1harA Contact us; website: https://bit.ly/2W1nV6r Email: [email protected]