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.