3 ways to change your mind regarding risk management
I hate Risk Management. There, I said it. And I am not the only one actually. Many of us are thinking that the Risk management is terrible! Please note that Risk Management is integral part of medical device and nobody can do away with this, so it needs t be embraced. With feeling of hate it will be difficult to implement this process with true potential. This system, no doubt is slightly complex and requires some training and in-depth knowledge for its application. Once done then life becomes easy. It is confusing and lengthy to induce through. you have got no real idea if you’ve covered everything or if you would like to stay going further. And once you get into probabilities and severities, it seems like you are just guessing. Though this is true but once mind change happens and you start using the same you learn a lot. Couple of guideline documents are available. ISO standard 14971-2019 is latest standard on this which also describes a lot about what is risk assessment. ...