Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing ...

Hello Everyone, It is critical to know which steps can be taken to successfully go through project initiating phase as quickly and efficiently as possible. To be a good project manager, you should kno...

First of all, person/company needs to find out if this product even required RFD because not all product required RFD submission. The necessary step to take before submitting RFD with a better underst...

Hello Everyone, Human Factors study considered users to assess the adequacy of the combination product user interface design to eliminate or mitigate potential use-related hazards. Human factors study...

Hello, I think during capstone project the application your team developed is considered to be mobile medical app because it allows people to retain their auditory stimuli. Furthermore, mobile medical...

To be a good project manager, I think project manager should have certain skills in order to be effective and successful. I agreed with above posts that communication skill is very important to transf...

Design validation is required to verify if user needs and intended uses are met; it can improve the launch success and reduce the chances of product recalls. In simple words, Validation is to check th...

Hello, I would like to work in a matrix type organization. Matrix organization is a mixture of functional and projectized organization structure which helps employees to perform well, allows enhanced ...

Hey Roberto, The topic is very interesting. Lamiaa has a good example why it is necessary. I understand, it is very competitive to bring something new in the market, and it makes sense that o...

Hello Everyone, As we all have little idea of legal aspects and how it works. We know outside of court settlement is best option which saves time and money, get more privacy and become less stressful....

Before taking this course, I had hard time figuring out what I could do as a biomedical engineers when I will be looking for industry based jobs. I have gained bit of knowledge now to know how industr...

Very interesting question. To be successful in the project, culture organization has a huge impact on your success rate. Your organization structure can help or hurt project success, it is easier to c...

Hello, There is a recent Gallup survey article about revisiting the matrix organization published on January 2016 which involved 4000 US employees highlighted some benefits in matrix organization. Sur...

While forming a project team, mistakes I would try to avoid are not been cooperative, lack of communication and effort. I think I would like to work with people who I am familiar with, it is always ea...

I agreed with above discussions. I think it is very important for doctors, surgeons or who else is involve in using that device to have a training or at least instructions have been read before using ...