@sameer-rana I agree that the project and matrix functional structures can be better suited for most companies. In a project-based organizational structure, planning and execution are carried out as a...

@shereenmurrah I have worked in a functional organization structure mostly and I see the many benefits of this setup. This functional structure describes the common structure of a company with a posit...

It is hard to pinpoint which functional structure would be the best because of many different factors. Each structure comes with benefits and risks, and certain companies might find this useful. In th...

@ao242 Looking at patient preference is important in understanding how the risk-benefit assessment impacts patients. Certain patient information is more favorable in testing for the success of the me...

@k-faulk Looking throughout the thread to identify common risk management errors is a good idea. These mistakes are major and impact how long the product will be on the market. Each of these major mi...

It is understandable that certain companies are not using the risk management processes correctly. Each part of the risk management process plays an import role for proper execution. The risk manageme...

@mrlee5 You described the necessary use of Design Controls in other countries very well. Design controls are a series of processes that ensure a device is safe, it works and meets the needs of the mar...

@niya-j I agree that the purpose of Design Controls goes far past just planning for a medical device to make it to market. Design Controls provides an extensive series of steps and documents that che...

Design controls are a series of processes that ensure a device is safe, works, and meets the needs of the market. The US design control regulation falls under FDA 21 CFR Part 820 and ISO 13485:2016. T...

@niya-j I agree that both sides of the argument have a complicated choice when it comes to what is ethically correct. An Informed Consent form is necessary for obtaining proper documentation of patien...

@kc4310 I agree that once patient consent is given, they should be able to proceed with the test treatment that is being offered. There are other issues that could arise as a result of this decision. ...

There are many ethical issues behind initial clinical studies in small groups of volunteers for the study. Initial study groups are small in order to test initial impacts on the human body. It is impo...

@carrissap10 I agree that blue is a popular color used in businesses to promote different things. Blue is a calming color that seeks to create peace. In most medical settings the color blue is used fo...

@mrlee5 I agree that certain products like Nike are easier to promote based on popularity. Their commercials enhance and showcase the products that they already have in store. They do have good commer...

Anytime there is a catchy song, phrase, and good-looking product; there will be an increase in sales. There are many commercials that consumers can point out by background music or beats. For example,...