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...

As mentioned, several companies use different methods for advertising rather than traditional 'tv' or simple video advertising. Many companies used word-of-mouth, targeted mail-in offers, or offer dis...

Reading through the replies, there are several good points brought up like: the internet has changed to allow a higher range of products to be advertised, the easier expansion of your consumer base, t...

@dag56 , agree using a celebrity is definitely an effective tool that's used in todays marketing to further connect with the intended audience. Another example of a celebrity very well used in Marketi...

@reginabarias Yes! Thank you for bringing up the points that its difficult to land a 'dream job' right after college, and that you may end up staying in the job that you land longer than you'd like. I...

Reading through several of the comments here, I noticed many were of the opinion of choosing an LLC; justly so since there are many advantages like limited liability and the potential for dividends. T...

@as934 , reading through the other posts, agree this point is not mentioned and is a good one to consider. Tying into this point, the type of corporation chosen also depends on the future intent of th...