@an83 Exactly. To add onto this, from the outside, it seems it may be difficult to even grasp a consulting position in the first place as a new graduate with-assuming-little to no experience. Consulti...

@hc255 agree; I also firmly align with how you pointed out that this doesn't necessarily have to be a scary thing. It is indeed important to ask and well understand what's considered confidential, wh...

@rm829 , very true and I wanted to especially highlight one of the points that you brought up. Something important consider is location as it relates to the physicians specialty. Simply considering so...

@ag2357 , to play the devils advocate to you and @kaf43's suggestions to increase communication-what if increasing this communication within the organization leads to issues? How would increasing that...

@benjaminrofail , I agree. However there's another important point that should be made here. A good project manager will make their choice based off of what they know and what makes sense. By that I m...

As having worked in a Functional Organization and a Matrix Organization, I can say that my preference between the two has been the Matrix Organization. Within the Functional Organization, the pro was ...

My company has used the FMEA document to analyze risks. Although we also do have the the Ishikawa Diagram (Fishbone Diagram) to analyze risk-the general preference for my company are the FMEA docs. I ...

@dbonanno1 exactly, agreed with what you stated here! I think its also important to note that the question of "What could go wrong with this product" should be applied to the SME's. The SME's are the ...

Several others have made very valid points already in that using an Acceptance approach doesn't necessarily increase risk. However, I think its very important to distinguish that using the Acceptance ...

As many others have said, it is important to conduct the human factor study if the device is to be used in the human body. Although the guidelines may be general regarding what'd needed for these stud...

As others have mentioned here, meeting minutes are useful for keeping the team in the loop as to what was discussed in every meeting. This is true, however, typically the project manager would send ou...

Verification vs validation can be tricky to understand sometimes. Sometimes its helpful to view it as a 'what makes sense' in that moment when it comes up to verifying or validating a device. One exam...

@krp67 To add onto this and emphasize you're point; yes these drugs do need to go through animal trials first, but they then must be confirmed with human trials. As you mentioned, the human body is no...

A double blind study greatly improves the authenticity of the study results and removes bias from both and patient and Investigator involved. To give an example, if you provide a swatch of color to a ...

Having a clinical background seems to be used as a filter by many companies to recruit talent with a certain background and make it so those who do apply without that experience and get in-are exempla...