I was able to find a kickback allegation that happened very recently, this past September 2017. It involves Galena Biopharma with a prescription opioi...

As a person who has been working in the medical device field for multiple years, before I started this course I definitely was not sure what to expect...

As others have said in this thread I think it is very crucial to ensure that everyone attending / participating in the risk management meetings have a...

From my experience and in my opinion I do not think the risk associated with a specific product performance (or lack thereof), should have a major imp...

I currently work as an R&D engineer for a medical device company, and have had some experience with working with the QA (quality) department on ri...

If any requirement in the Design Verification (DV) Protocol is not met during testing you will be unable to complete DV until this situation is rectif...

It seems everyone in this thread agrees that the determination for the appropriate sample size for statistical analysis stems from what your desired c...

I actually have experience working as a test method development engineer for a medical device company (Becton Dickinson), working as this role your ma...

Based on my experiences working within relatively big medical device project teams the two biggest things that I think are very important with regards...

I do have experience attending a few design reviews and also leading one. From my experiences design reviews are exactly as everyone has been describi...

If I was involved in clinical research trials I would like to be a monitor. I would enjoy being able to monitor the clinical trial participants heath ...

Yes, I do think that Placebo-controlled trials are both ethical and necessary. When performing any scientific study, I think it is very important to h...

I would start out by saying the obvious, which is that since companies are willing to people as a CRA without having any clinical background would mea...