The thing is that what you may be working on (as covered by an NDA) may not be sufficient to be apply for a patent. You may in fact be needing work or studies done by a contractor or collaborator to h...

The biggest difference between a written and oral contract is that a written contract can easily be defended in court, while an oral one requires additional evidence that can stand up in court. If the...

Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how it is rea...

It's been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other projects. Sometimes, people with some expertise or know...

So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: Say you were to start up a medical device company that will function worldwide. What type of orga...

My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. However, while there are projects that involve vario...

The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design input and then critical development parameters were...

Two other methods are: Hazard Operability Analysis (HAZOP) - Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brain...

I've wondered about this as well, especially because in academic research I've needed to look at ISO standards and I wasn't going to pay for them. I found this information given by ANSI: It seems it ...

This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? I ask because typically for drugs and biologics, t...

I can only speak to my experience, but generally it's been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more just for documentation purposes. The team or proje...

If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characterization techniques that have been used to measure...

I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required for production. It is usually larger companies that...

Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing,...

It seems that the DHF is superior to the Design Dossier or Tech File in it's thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead. From the...