Collaboration and content governance sample: Abre IFU (Instructions for Use)

This IFU was outdated and needed to be updated in order to satisfy regulatory requirements in multiple geographies. The US version of the IFU, which can be seen here, was updated to include data about the product that is required by the FDA. I worked to ensure that all content that could be reused between geographies was reused, but that necessary distinctions were also made. Click through to read about other unique challenges in this project.


Lons Nadziejka Waller

10/12/20201 min read

Clinical data and NDAs

For this project, I built parallel paths for writing/updating the IFU. The clinical data was confidential at the time of writing and only part of the team had signed the NDA that allowed them access to the information.

This meant that I was holding meetings for, collaborating on, and writing/updating 3 versions of this IFU at the same time:

  1. EU MDR

  2. US with clinical data

  3. US without clinical data

Once the clinical data was no longer confidential, I combined the US paths and moved the IFU through the approval process.