The lecture emphasized that documents like the DDP are “living documents.” This continuous update process helps ensure design alignment as the project evolves. However, constant updates can also create confusion and documentation fatigue.
How can organizations balance maintaining up-to-date documentation with preventing inefficiency or information overload?
This is a really good point about the updating process of living documents within the medical device process. I think organizations can balance maintaining up-to-date documentation while preventing inefficiency or information overload by having the project team note down any changes they made to any aspect of the medical device or testing process throughout one week. After one week, the document is updated, and there is a project meeting held to discuss the status updates, so everyone knows what is happening with the device. Since this process is weekly, everyone will be up to date on what is happening, and the document will be periodically updated so as not to cause information overload.
That’s a great point — keeping “living documents” like the DDP continuously updated is essential, but it can easily become overwhelming if not managed well. One effective approach organizations use is controlled versioning and scheduled updates rather than real-time edits for every small change. This ensures the documentation remains current without constant disruption.
Another key strategy is clear ownership and communication channels. Assigning specific individuals or teams to manage updates helps maintain consistency and avoids multiple people editing the same document independently. Additionally, summaries or change logs can highlight what has changed since the last version, so team members don’t need to reread the entire document each time.
Ultimately, the balance comes from treating documentation as a tool, not a burden—updating what’s necessary for design traceability and regulatory compliance, while avoiding unnecessary edits that add noise instead of clarity.
