Hello,

This is an interesting article. While I do agree that yes, companies can make these common mistakes, it still does not hurt to follow a process. The article mentioned that risk management is looked at as a “checkbox” activity. The checkbox is there to guide the company on brainstorming the potential risks and figuring out how to prevent or minimize them. Without it, it is very easy to get lost in the mayhem, so to speak. Where would one start when beginning a risk analysis?

When determining risks for medical devices especially, companies need to expect the unexpected. This means that the analysis will be done in several sittings instead of one and over the course of a period of time. Problems are always bound to arise and not 100% of them will be recognized. Therefore, following a checklist can be a good thing, at least to keep the company organized and help the engineers on track as to not forget about certain risks.