Is it better to design communication management plan just once for all the project in the company and documenting it as a SOP or is it better to have a communication plan that is specific to a particular project. I…   Read more»

Factors other than matrix that can help detect the status of project and help us have rough estimate of time frame on the project

Change is an integral part of a project but when changing something in a project it affect various things like schedule budget planning etc so what are the things we should look for while evaluating a change request.

In this weeks lecture we learned about Schedule variance, cost variance, Earned value and planned value and actual cost. As professor suggested that to identify project health important parameters are cost variance, schedule variance and earned value. An ideal project…   Read more»

In medical device industry when a company outsources one of the part of the device what point should a PM look at while selecting from a list of different vendors and how would this points changed based on the criticality…   Read more»

In planning phase I think if proper care and hard work you can make a perfect Gantt chart but one thing to almost impossible to get correct in it is to cover all pitfalls. So what are the ways you…   Read more»

In Design input document marketing Team brings most of the specification for the device. What would be the most efficient way to brings this input and who else can help to bring in more specification so that device can be…   Read more»

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

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 .

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 and use this…   Read more»

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 in Matrix structure but than more frequent bargain between Project…   Read more»

I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and doctor will have…   Read more»

Especially in medical device companies when product are in developing stages how can a company like verb or ethicon which are working on new technology or are about to launch a new surgical robot how would the companies be able…   Read more»

From the lecture as we saw that major work of quality department is to oversee if all other department have abide to procedure which are set by regulatory boards in order to get certified and if a department doesn’t abide…   Read more»

I was wondering that why are the recall either made by company or made my FDA are of items which have been in the market for at least 5-8 years after the launch in market. Why cant they be either…   Read more»