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 ...

Posted by: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: Say you were to start up a medical device company that will function worldwide....

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 s...

@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 yo...

@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 yo...

Do you believe risk management is an important part of the planning phase? Is it necessary or it is just a waste of money and time? Why?

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...

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 n...

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 c...

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...

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 v...

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...

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 someti...

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 pa...

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 filin...