Efficient medical device documentation

"Where did all the hours go?"

It is a well established fact that a large part of the medical device development effort is made up of producing documentation. The 30+ participants of the Aligned morning seminar "Death by documentation" in Kista, Stockholm, were all too familiar with this situation.

Regulations such as ISO 13485 or FDA QSR 820 require us to produce documented evidence that our product is safe.

Sometimes, however, there is an overwhelming feeling that documentation work undertaken does not necessarily fulfill this requirement. 

At this seminar, we explored the drivers of excessive documentation in the search for plausible causes for the documentation requirements to get out of hand and the recognizable effects that let us identify these drivers.

Although the solution to the documentation problem of a particular company is likely to be found in the specific circumstances of that company, asking explorative questions about documentation aspects can unveil overlooked root causes for excessive work.

Examples of such questions are:

• "Why are certain documents modified more often than others?"
• "Why do certain documents involve more people than others?"
• "Why do certain documents take longer to complete than others?"
• "Why do certain documents exist in more instances than others?"

In many cases there exist perfectly reasonable answers to these questions. In other cases, these differences might not be called for.

Identifying documentation drivers and eliminating unnecessary work can help us to reallocate valuable resources from documentation to innovation.

This event is a cooperation with Qadvis.

The seminar presentation can be found here.