-
reshamn replied to the topic How to ensure your DHF is audit ready ? in the forum Introduction to Design Controls 7 years, 5 months ago
One thing to point out about a DHF is that every team member who is involved in the planning/development of a particular medical device should have access to the DHF. Sometimes, new recruits might not be given access just to prevent any mistakes. However, that actually might lead to some missing information that was relayed from the new recruit but not entered in the DHF. In order to keep this as thorough as possible, make sure the whole team has access to it. Everyone who contributes to the project should be able to make notes and update the DHF.