Medical Device Courses | Annie | Mentions

Sid replied to the topic "Should Medical Devices Be Updated Like Smartphones ?" -

Sun, 15 Nov 2026 04:04:10 -0500

@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»

James Olson replied to the topic "The Role of Different Users in Device Development" -

Wed, 04 Nov 2026 23:28:10 -0500

@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»

James Olson replied to the topic "Who Should Be Responsible for Quality: Engineers or Dedicated QA/QC Teams?" -

Sun, 04 Oct 2026 02:21:47 -0400

@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»

enzo.1216 replied to the topic "Why Product Claims Matter in Medical Device Regulation" -

Mon, 28 Sep 2026 01:35:35 -0400

@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»