Team development is an integral part of leadership

Team development is a critical aspect of leadership, because leaders, like statesmen, think about the next generation. Leaders not only select and mentor leaders; they also make sure the leadership abilities get transferred to the new generation. For this reason, taking the organization to its next destination and grooming leaders requires team development. Team development […]

The Device History Record (DHR)

The Device History Record (DHR) The US FDA states the following: Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR’s for each batch, lot, or unit. The purpose of this requirement is to show that […]

Is a completeDevice History Record a must?

Is a completeDevice History Record a must? This is the same as asking if a teacher needs to complete her entire syllabus for the class. There is considerable debate in the medical devices industry circles about whether some portions of a DHR can be done away with. Please, please, do not take the DHR for […]