Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experi...

Posted by: @dbonanno1 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 ...

Posted by: @fo3 As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or cont...

Posted by: @orleron It is important to understand the process of Risk Management which includes Risk Analysis and how this is a living process that flows throughout the entire medical device developm...

Posted by: @fgk4 The ISO 14971:2012 "Risk management for medical devices" requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundr...

Posted by: @jnm22 As I was going through the lecture I realized a lot of risk management is done before the product hits the market or done on the company side. This made me think of labels and instr...

Posted by: @shfrancis @jonyekwere Hi Julian, since you work in the "regulated production setting" would you prefer to work in QA or QC? What are the roles of the QA and QC person in a research labora...

Posted by: @kbs27 Design transfer which is an integral process in the early life of a product, it must be well executed for complex medical devices.And as Professor mentioned if it satisfies the FDA ...

Posted by: @hg93 Design Development Plan (DDP) contains:*final scope statement*scope management plan*quality management plan*communications management plan*team member list/responsibilities Communica...

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the...

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 sometime...

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 k...

Posted by: Josh As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or other ki...

Posted by: reshamn "Piercing the corporate veil" refers to a situation in which courts put aside limited liability and hold a corporation's shareholders or directors personally liable for the corporat...

Posted by: Josh What is a Mission Statement and a Vision Statement? Why do you think they are important? Find some mission and vision statements online for some of the medical device companies out the...