Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement…   Read more»

Posted by: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: http://blog.hubspot.com/marketing/team-structure-diagrams. Say you were to start up a medical device company that will function worldwide. What type of…   Read more»

Posted by: @zcornelius21 There are multiple types of organizations within project management that have there own way of playing a majored role in how projects are carried out. How do organizational structures affect projects and project management? Organizational structures affect…   Read more»

@traceymraw I agree with you Tracey. You make some really interesting points in your reply.  Some risk are necessary because they are unavoidable for the effectiveness of the product.  The examples you used are great as well.  Like the bone…   Read more»

@traceymraw I agree with you Tracey. You make some really interesting points in your reply.  Some risk are necessary because they are unavoidable for the effectiveness of the product.  The examples you used are great as well.  Like the bone…   Read more»

Implementing risk management is a benefit because it allows the medical device company/ manufacture to be ahead of the game. It allows them to release the warnings and side effects before anyone has a chance to experience them when the…   Read more»

I believe that minutes of a meeting are important because it is a very detailed and organized document that entails everything discussed.  The meeting could mention how the company is implementing a new procedure soon and that everyone needs a…   Read more»

Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

I agree with @samscott.  Being that all the research is being done in real time, we can not sit and compare multiple data points to test your theory @mejefferson.  I would like to think that certain vaccines work for certain…   Read more»

Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and…   Read more»

Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2…   Read more»

Posted by: @tulikadasp A DBA( doing business as) allows a company to transact business using a different name. It generally takes place at the county level, but some states have state-level DBA filings. For sole partnership or partnership, unless a…   Read more»

Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

Posted by: @sahitya-sadineni Although science has been around for a while, technology is something that has been evolving in the past 20 years. Pre-clinical is very important to every and any kind of medical research. But what is also important…   Read more»

Posted by: @yroberts Preclinical research trials are know to be performed on a single lab creature such as rodent, pig, fruit fly, or monkey. Most recent research appears that having an animal model and conditional differences in the studies can…   Read more»

Posted by: @arianaburch If you had to select right now if you would work Academia or Industry, which would you decide? Their approaches to research are different and yet similar at the same time. Did their approaches to research aid…   Read more»

Posted by: @mejefferson The medical device development process requires specific stages to be followed to ensure design control so that the product is both effective and safe for use. As a result, this covers the entire product development cycle, from…   Read more»