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 according to nature of primary job it was origina...

When a device is upgraded from previous model does it require total FDA evaluation or only upgraded parts needs to be re evaluated.

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 to classify in class 1 device and is not going to l...

What happens when a current model of the device is upgraded ? Does the upgraded model has to reaplly for the approval or only specific parts which are updated has to be re evaluated by FDA .

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 primary purpose for device for example its a antibioti...

In NDA we decide length of time for which we share the information for how much time is this information is shared is based on the project deadline but isn't it possible for the contractor to modify a...

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 something that is good for them just because sales ...

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 that really I found useful that this course was more ...

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 want to break the agreement But if you really imp...

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 Matrix organization are very effective where it ca...

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 for person who want to work in department. the only ...

There were three types of organisation we discussed in the lecture Functional project based matrix Functional and project based both faced inter department silos there was less inter department silos ...

Few of the mistake that company make that I came across are 1. Not considering opportunities – just threats 2. Confusing risk causes, risk events & impacts 3. Using checklists and not ‘scanning th...

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 if the device specs are not withing the device sp...

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 cycle, there is never 100% certainty regarding the ...