Hi, my name is Fubin Wu. I am the co-founder and president of GessNet. Over the last 10 years, I have been helping companies on the development of safety assurance cases, which are basically telling the stories to the FDA why a particular medical product is safe. Developing a safety case is the best learning experience ever as it requires connecting the dots of how what's been done matters and why what's been done is adequately good. I have created this blog for sharing my learnings and also use it as a platform for receiving comments/thoughts from those who may share the similar interest. I will start with the list of key takeaway topics, eventually cover all the key areas with more details. Further more, I have my software development team working on our next gen software solutions - QMSpace, which will incorporate all the learnings and intuitively guide an organization to develop and maintain a safe and effective medical product from the get-go and throughout the product life cycle. If you are interested to know the details, feel free to sign up for demo though our company website contact page.
Fault Tree Analysis Graphic Editor:
automatic integration with hazard analysis and FMEAs
design Control Trace Matrix