Of course in the medical device industry they say “if its not documented, it didn’t happen.” So capturing decisions made and the logic behind the scope of the discussion is always valuable. In my personal experience, I’ve worked on Design Changes with as little as 2 design reviews and one I am working on now has at least 6. This project is based around expanding sells to the china market, so we have to make our product meet their regulations. There are documents flying around in Chinese, there are changes to the design input requirements, and there are labeling updates, and project scope changes so needless to say this is a huge cross functional effort. I think the most critical thing I’ve done was documenting review of documentation before we send them to CQC and review of documents in Chinese with an in country representative from China Regulatory. This project is very dynamic and a culmination of decisions made by multiple people so I and glad that the design reviews allows traceability and transparency of the project. Essentially, I feel like I am leaving bread crumbs leading to the end of this project.