Great question! While paying only for the doctor may be very restrictive, I understand the point of not allowing these forms of compensation for physicians due to the perspective of bribery. By consis...

I must say, after taking two courses with Dr. Simon, his courses are one of a kind. Your typical course includes learning theories and understanding key definitions of the course but these courses in ...

The confidentiality agreements are essential to protecting confidential information shared between companies. I agree with @kaf43. Certainly, the pay would be one of the most important points to discu...

Personally, I believe I would be best suited for a middle management role. Upper management typically require a certain level of "global" expertise and overseeing the entire organization while middle ...

As discussed during lecture, the Design Development Plan should contain the Gantt Chart, WBS dictionary, Network Diagram, the budget, schedule, resources, and all other project sub-plans. The sub-plan...

The Gantt Chart is a visual representation of project schedules whereas the Network Diagram is a representation of project workflow. The Gantt Chart may be used to manage project resources, time, and ...

For risks of low severity, as there is minimal threat, risk acceptance may be the best option. Depending on the threat posed, one may choose risk mitigation if it is worth the cost however it is optio...

An instance where the risk is worth acceptance is when dealing with biologics in medical device development. While biologics such as vaccines, gene therapies, and therapeutic therapies each have speci...

An example of a hazardous situation is the exposure to many biohazards and chemicals within the laboratory. Inside of the laboratory, professionals deal with patient samples and many different chemica...

I believe the user/customer feedback is the most important aspect in design controls. When companies consider the needs of the customer, it displays the company's willingness to build and maintain the...

Other challenges that may occur in design transfer include incomplete manufacturing instructions, errors or an incomplete design documents, lack of inventory due to miscalculations for cost of materia...

The main source for the design input comes from marketing. During product development, design controls are compiled based on market need for the product, ideas that fit the need, and ensuring the prod...

Meeting minutes are essential in keeping record of meetings. During these meetings, critical information is discussed such as any modifications to the project, project status, discussion of roles, mil...

As a validation engineer, I think the first step after a failed validation is to question why the product failed validation. Depending on what it is that caused the failure, there may need to be modif...

The Design Input Document (DID) provides the physical appearance and basic performance of a device. The Design Specification Document (DSD) is a detailed document that provides the exact specification...