-
akshayakirithy replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices 7 years, 8 months ago
For a Risk Management Meeting it’s really important to have all departments heads. If there is any change in the design, then it affects all the further steps in a mild or a severe way depending upon the change. Whatever it is we have take everything into consideration. In regulatory, the changes should be checked whether it is under all the regulations to be followed. Also, in Preclinical the testing strategy might be changed due to any effects. This applies in Clinical trials also. Majorly Marketing people should give a detailed report about the profits and loss regarding the changes with respect to the customer details.