As Murad and others have mentioned, meeting minutes are crucial for capturing meetings and holding meeting attendees responsible for decisions and actions. In my opinion, the concept of using meeting minutes is beneficial in every single industry, not just the medical device or pharmaceutical industries. In my experience, meeting minutes are very…[Read more]

I think that even though Gantt charts are meant to document all of the related activities for a project, I think overall flexibility is key to delivering a project.

Sort of related: A common thing that happens at my job is that project teams know their drug file date a few years in advance. While that is helpful, sometimes it causes the…[Read more]

I think the DHF mindset of continuously documenting the “whole story” is more beneficial than the EU approach, where the design is evaluated at a single point in time. I think that documenting the entire development process and rationale for key decisions (which is done in the DHF) is advantageous when issues arise in the manufacturing of the…[Read more]

I agree with you, John. As others have mentioned, companies that have developed legacy products must have some level of documentation on the design and manufacturing processes at minimum. I think that it may be worthwhile to compare their level of documentation with a DHF to identify gaps, but I think if the gaps are small and the history of the…[Read more]

Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As you mentioned in your example, when the people responsible for development & documentation of the device are not on the same page as the clinical team, it could cause misalignment and the necessary…[Read more]