Something that is related to this lecture that was not talked about is a "Non Compete Agreement". Usually bigger companies will make you sign a non compete agreement before you start working there whi...

I was able to find a kickback allegation that happened very recently, this past September 2017. It involves Galena Biopharma with a prescription opioid scheme. Galena Biopharma had to pay more than $7...

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 far as the class content / structure. I can ho...

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 thorough understanding of exactly how the product...

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 impact on the sample size that you use for testing. S...

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 risk analysis. As our professor has mentioned in thi...

For medical devices that are not used inside of humans / animals, and do need include any kind of medication dose accuracy are Clinical & Pre-Clinical Trials needed? or will Design Verification an...

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 rectified. I have been in this situation before and ther...

It seems everyone in this thread agrees that the determination for the appropriate sample size for statistical analysis stems from what your desired confidence and reliability levels. At the company I...

I actually have experience working as a test method development engineer for a medical device company (Becton Dickinson), working as this role your main job objectives are to develop and validate test...

Based on my experiences working within relatively big medical device project teams the two biggest things that I think are very important with regards to creating /managing gantt charts are the “criti...

I do have experience attending a few design reviews and also leading one. From my experiences design reviews are exactly as everyone has been describing. They are important milestones within the medic...

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 throughout the study, and see what the effects are...

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 have a control to be able to compare the effects of...

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 mean that it is not a complete necessity. On the othe...