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: @mmd55 I recently received a job offer and while reviewing my offer I noticed I would have to sign a non-compete agreement, which is an industry standard. I asked the recruiter if I would ...

Posted by: @cef3 Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard ...

Posted by: @hg93 As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and ...

Personally I seem to like the idea of a Project Based Organization structure. To answer your question on which type of medical device company would benefit the most from this, I would imagine one whic...

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project ac...

This brings up a fair point. There is only so much a company can do to reduce the risk to their consumers. At the end of the day, there is not going to be a representative of every company in the hous...

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: @rajamharrison 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? Risk management is an important pr...

As Ridmehta, mentioned most major projects will come with some surprises. It may be impossible to map out perfectly when each segment a project will be completed down to the minute. However, the Gantt...

Hi Hodafattel, I do not work in the industry, however, I can elaborate on each of the two terms which you have mentioned. Validation is quite important in a product, but it may not need to always be p...

Posted by: @tulikadasp Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes ...

An instance were I had to create a Gantt chart for the project which I was working on was actually my first time doing so. I think the key when creating one is to have in mind that the Gantt is just a...

During the slides on design verification, it was mentioned that for verification it is advantageous to catch the issue in the design before the verification protocol and report have been initiated. Ca...

Posted by: @orleron The DMR is largely used for US products. It is required by the FDA. The equivalent to the DMR for European products is called the Technical File (for European class I, IIa, and II...