Posted by: @vcf3 What tips can you give for a new Project Manager who has never been in that position before? I saw this article () with some useful tips, but I want to hear your real-life tips and e...

Posted by: @devarshi-joshi Validation is the process of surity that you have objective evidence that are needed by the user and the use of-course. Verification is typically making sure that you are h...

Wow. There have been some really great and informative answers to this question.For myself I agree with others on the point that technical education is necessary but not sufficient for success. Howev...

@jvv6What skills would you mainly prefer if you had to build a project team.A team having the set of technical expertise for the project at hand is a must.However, I think a few added skills that woul...

No there is nothing that should be done about this. General attitude being conveyed is that gifts are not to be used to unduly influence healthcare providers in their decisions. Regarding the lack of ...

When a company is engaged in building a medical device, the company may not have all the areas of expertise hired as employees. Resource of a domain expert may or may not be required on a long term ba...

An NDA is definitely not a substitute for a patent. 1. The scope of a NDA's application is limited to the two parties explicitly included in the NDA. A patents scope of protection implicitly includ...

Wonderful question. I work in a matrix organization. Interestingly, it was originally more of a functional organization. But in an attempt to be more effective in addressing project needs a decision w...

We had our first in person meeting two fridays ago. We spent most of the meeting defining relevant requirement for the DID. It was a fun collaborative experience. I have worked in the industry for som...

In my opinion the best organization structure is the matrix.It provides the best balance between maximizing human resources utilization and role specific development via representation at the a the ro...

Definitely in agreement with much of what has been said.Two ideas put forward so far best capture the contrast between the DID and DSD.The idea that they are each for different audience, and the idea ...

There has been much offered so far to answer the question "What are Design Controls".Working at a medical device company fory several years i would like to offer what i observed from my experience. N...

There is no complete correspondence between animal testing and humans.Doing tests on tissue apart from a live person is not always possible.So there is no way to get conclusive results wi

I think consent should by all means be secured from patient prior to using materials or data from patients. It is crucial people and therefore patient have complete control over THEIR being. At the co...

A double blind study help to eliminate bias of doctors participating. It is within the realm possibility to have a doctor whom may be willing to influence a study out come for monetary gain. The docto...