In my company, there are 2 main categories for our testing deviations: deviating from a standard, or deviating from the protocol. For testing our impl...

I think the best strategy is to get the disagreeing parties together in a room and have a face to face meeting so that everyone can understand the ful...

A good way to prevent scope creep is to gather inputs from the customer early on in the project and lock down the scope as early as possible. I agree ...

In my company, the first step in performing a change is to submit a change request via our Windchill software. This request goes to the change adminis...

I agree with the posts above that state that it is important that medical device companies have both a proactive and reactive risk management system i...

I agree with the 6 steps outlined by moniquet07. I would just like to elaborate on the importance of the PM developing the the task scheduling with in...

I have experienced this situation several times in projects, and I believe that often it is due to a lack of understanding of these seemingly simple p...

Similar to Viraj D, I'm familiar with FDA regulations from my experience in industry, but I really didn't understand EU regulations until I took this ...

In my company our process validations include machining validations, welding validations, validation of assembly fixtures, and finishing validations, ...

Although proper use of project management tools can definitely mitigate the risk of pitfalls, as wms7 mentioned, even in relatively simple projects, t...

From my experience with working on projects in industry, I would agree with the above posts that often during a project, it is necessary to go back to...

I did my undergraduate degree at NJIT in ME, and I thought that I got a decent amount of exposure to technical writing, especially in the form of lab ...

I agree with the posts above that the inputs for the DID should be gotten directly from the end user or customer. In my company the marketing departme...