What is lurking in the Design History File? - a manufacturer's perspective

Generating the medical device development documentation making up the products' Design History File, stands for up to 30% of the total development effort. Putting in these substantial resources ought to provide top-notch quality and very few errors in documentation.

Still, Documentation not available, or Documentation not adequate are frequently cited deviations in FDA Warning Letters. The reason for this flood of FDA 483 warning letters, addressing seemingly obvious and simple errors, is not that the medical device manufacturers are ignorant or incompetent.

The documentation requirements are many and detailed, the development projects often spans over a long time-period, involves a large number of alternating team members, all contributing to the large set of deliverables that make up the Design History File / Technical File. The deliverables are highly interdependent and a small change can cause unexpected ripple-effects over large parts of the documentation.


This combination of large volume, frequent changes and a high level of document interdependencies makes it impossible for any single employee to get a comprehensive view of the current documentation consistency at a particular point in time.

This is where automatic checks by a dedicated computer system really helps out. To illustrate this point, let us share some insights from a medical device manufacturer that ported existing Design Control documentation into our Medical Device ALM Aligned Elements and analyzed it using the automatic consistency checks.

Seeing is believing

"We found inconsistencies in the areas of design control structure, missing and inadequate traces as well as formal aspects of the risk management." says the responsible engineer. "We knew about the problem with the risk management and did not have too much confidence about the traces, but the other inconsistencies were new to us".

Applying the sort of systematic, automated analysis and support a tool can offer, not only unveils gaps in the documentation. It also makes deviations from formal documentation requirements explicit. "In the past, we did not work with a tool and then you have more freedom to find solutions, which in themselves are not wrong per se, but at the same time may be a bit outside of the ideal structure." he continues. "As time goes by, these design control documents are modified and deviates further and further away from the ideal structure."

This is a typical way in which inconsistencies undetectably find their way into the documentation. No up-front errors are committed, but over time, the collected aggregation of minor, grey-zone adaptations undermines the overall documentation coherence. In the end, the consistency of the documentation is unknown and the confidence in the work deteriorates.

"We might have underestimated the benefit of adhering to a clear documentation structure. At the moment, we know that we have structural points to fix. When this is done we can focus on the content. I am confident that, in the end it will be easier to defend the documentation, when the formal aspects are not in question.", concludes the customer.

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