@31623940 I think one of the main issues with this approach is that companies could play down the impact of a change, either intentionally or unintentionally. Also without a strict criteria on what is or isn’t considered a large change,…   Read more»

@31623940 I agree that the intended setting and user for the product greatly affects how the design should accommodate the user. I would like to bring up that decisions are often made to prioritize making the device as accessible as…   Read more»

@jfm23 I agree that QC/QA should be an independent body, specifically to ensure a QC/QA professional is always in the building. However, as @31623940 touched on, the responsibilities of QC/QA should not only fall on that body. I would consider…   Read more»

@31623940 I totally agree. I also wanted to add that I don’t necessarily think involving regulatory professionals early in the process would unnecessarily slow down development. There may be situations where their involvement does add more time, especially if the…   Read more»