I really think that the 2 most important things to remember when contemplating if you will sign an NDA is the credibility of who you are dealing with and making sure you have completely read and under...

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...

Posted by: @orleron In this module we learned about organization types and how those can affect medical device projects. What type of organization do you work in or what kind would you like to work i...

Risk must be identified during the planning stage of the project development process. This way the risks can be strategically observed and categorized. It also gives the team a chance to find methods ...

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? I think the risk is worth the effort if the p...

Posted by: @dparekh Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.We...

Posted by: @savery115 Statistical sampling is required for design verification and validations. If you have worked for a company or written protocols in the past - how have you explained or ensured t...

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Bef...

Posted by: @tulikadasp Clinical trials for medical devices have many similarities to drug trials, there are some necessarydifferences in the way the trials are designed and carried out. And in some c...

The ethical concerns related to the use of clinical trials that require human subjects are complicated. Primarily, these issues are hard to deal with because sometimes animal models and normal in vitr...

Clinical studies are dangerous for some drugs but they are a necessary process of drug development. the benefits are that through the use of clinical studies drugs can be finely developed for a larger...

Posted by: @amd29 When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical ...

Posted by: @manolo Advertising is a component of marketing. The way a product is promoted/advertised is what most average people notice about a product. What was a really great promotion/advertisemen...

Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public compan...

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...