Now a days many companies have been trying to release a multi purpose device with combination of drug and device. In this case products are classified...

I was also lately scrolling through the topic and first thing I found that this types of devices are not yet classified under fda but it has drafted t...

There have are many instances when the device has dual capabilities which falls in both the CDRH and CDER but first we have to determine what the prim...

I really agree with everyone above that Kick-back law is one of the thing to make sure patient gets the best service for which they come for and not s...

I liked this class a lot for the sole reason I got to know where to work and what things are needed to get to the position I like. The other thing tha...

I haven't experienced it but one thing this non compete agreement mention mostly is that you have to pay certain amount of money to the company if you...

I think the best strategy over here would be one in which company can utilize its resources to the fullest. So i would say from company point of view ...

I would like to work in Project based organization. Since I would like to work as a quality or regulatory department and I see in this it is better fo...

Few of the mistake that company make that I came across are 1. Not considering opportunities – just threats 2. Confusing risk causes, risk events &am...

I think that it worth buying this standards from regulatory department because if they are the one who are gonna finally approve our product for sales...

Factors to be considered for benefits vs Risk analysis by analysis. Uncertainty:is an important factor, since at any point in the total product life ...