-
gy66 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 6 years, 7 months ago
Multiple different teams in R&D, at least at my company, must assess risks when developing a new product or update in software. On my team, we validate products and the software updates and test any bugs or even unexpected behaviors along the way. Anything that we notice, we immediately record and then discuss among each other of how high of a risk do the addressed issues possess. We strive to resolve all issues, however, addressing the severity of the risks helps us prioritize our resolutions. Often times, we call in our corresponding team in Europe and coordinate with our dental technicians to accurately measure the risks in certain cases. There have been times when we noticed issues with high risks and immediately worked on resolving it and even released a software patch just so they could be resolved as soon as possible. I believe the risk assessment strategies my team currently follows is both realistic and effective in managing different problems with our products.