I would select a team which listens to other’s view and give suggestion. An ideal team is one in which communication takes place cordially, as such there will be new ideas coming and the project will be doing a lot…   Read more»

I believe there are various skills which a project manager should have in order to succeed  like communication, planning, involvement, leadership etc. But the most important one as per me is communication with team members and listening to their view….   Read more»

Interpersonal skills are very important in any field, be in academia or industry. I have worked in an IT company and interpersonal skills play a huge role for the success of any team/project. Many a times it happens that one’s…   Read more»

I agree with Scott, that for working in an upper management it is better and preferred if we have already worked in a middle management. As it will aid in creating the timelines and vision of the company/project. I would…   Read more»

In our team, we met the very next Friday and discussed everything in detail and started discussing the DID plans. We have planned to meet every Friday and have also created a “Hangouts” group and have started posting updates and…   Read more»

A project is successful only when the team is good and the key characteristic of a good team is to listen to every person’s opinion. Each member of a team should be open for ideas and listen to other’s views…   Read more»

NDA and patents are different and they varies case to case, an NDA is a document between two or more people/entities which confirms that the parties will not share the document details and will not recreate it on its own,…   Read more»

I think it is important to have a written agreement as it can be physically presented in a court and it is more reliable compared to an oral agreement. Oral agreements can be presented in the future for any reference…   Read more»

It might sound harsh that in a diner a person can not pay for doctor’s spouses’ dinner but I believe the restrictions are necessary to prevent tampering from the companies. As has been the case, there are several pharmaceutical companies…   Read more»

Yes, I do believe it’s a grey area. But I get the point, the risk management will vary to a great degree from one device to another, so the ISO can not give a generalised list of guidelines or limits…   Read more»

Yes, I believe it is worth accepting the risk as some devices can not work if we remove the risk aspect of it, for example, a bone drill or a painkiller (when thinking of drugs). It’s just that the consumer…   Read more»

I believe what the company can maximum do is to warn them by labeling, the ultimate result will be how the user deals with it. Coming to medical devices it is very apparent that there will always be some kind…   Read more»

Design controls are tools for professionals to ensure that medical devices are designed, developed, and manufactured to be safe and effective. However, there are few issues that arise when these are not done effectively and where they fail like Poorly…   Read more»

I think there are few pros/cons to both the ways, but in my personal opinion outsourcing the manufacturing part to outside contract manufacturer is better. Doing this we get another idea and the work will be done faster as it…   Read more»

I believe both the documents are important as the product needs proper binding and specifications are needed in order for the product not to fail under any circumstances. DID is the initial document that specifies how and what the product…   Read more»

Verification is an important step in Design control. I would like to add some points in the verifications of a DDD mode pacemaker. It is verified using CTTS specifications which determines the voltage and power levels in a pacemaker using…   Read more»

Verification is very important as we need the design parameters to match with the proposed designs to avoid any faulty or any unavoidable damage. To make verification better i think the process should be very neat and strict without any…   Read more»

I certainly think that Minutes for Meetings(also known as MoM) are quite useful and must always be prepared during a meeting , as later on it plays an important role for maintaining the project towards the specified goal. When i…   Read more»

I would like to be a clinical research assistant and be in close connection with the investigation, reason being,  I personally like core biology a lot and it interests me to go in depth into the investigation and know the…   Read more»

For PCT I would say it depends upon the type of trial being under consideration I think they are pretty good to go with in terms are being ethical, as there is low risk and patients might get cured on…   Read more»