Fortunately I have had the opportunity to sit in on risk analysis session for a new product. The amount of time and effort that goes into creating the EURA’s (End User Risk Analysis) is very great. There are many different functions to look at when it comes to creating your EURA’s such as Process, Design, and Application. Like you mentioned before brainstorming is key, so while there is the fear of miscalculating or misinterpreting a risk, there are other members on your team to assist you in making these calculations. Additionally, quality will also review your risk analysis to ensure you haven’t miscalculated any associated risks. Again, teamwork is key when creating any medical device and that is shown here as well.

-Tarek