I have sign a non compete agreement before and did not affected me from getting another job that I want. To my knowledge, non compete agreement is an agreement not to enter into or start a similar com...

Oral agreement is as good as verbal agreement. A significant difference between oral and written contracts is that the time to sue for breach of an oral contract (the statute of limitations) is someti...

I enjoy the course and learn a lot. Although, I have some experience in medical device industry but this class has expand my knowledge and have me thinking of other profession in the field in can go i...

I would would like to work in Matrix Organization because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respec...

I would choose Matrix Organization for a startup medical device company that will function worldwide because of its flexibility to drawing employees from different functional disciplines for assignmen...

Middle management is lower in position to Upper management. As briefly discussed in class and mentioned by you, the upper management are responsible for making the primary and strategic decisions with...

Matrix Organization would be successful in collaboration projects in which two or more companies come together to develop and manufacture a product. Matrix approaches to projects and other initiatives...

One of the factors of Risk-benefit analysis according to FDA provided guidance is Patient Preference. It explains the importance of knowing any available patient preference information. Also to consid...

Risk management meeting should be ran by sharing the complied list of risks from previous project, if any in order to identify some common risks but also as a catalyst to get the participants thinking...

Labeling, instructions and warnings are required for medical devices. But least effective at preventing hazardous situations and foreseeable misuse. Another way to ensure proper use by the customer fo...

I agree Communication management plan is important but thinks quality management plan is equally as important. Quality management plan monitor and verify that project deliverables meet defined qualit...

To add to what has already been said, Verification makes sure that you have objective evidence that user needs and intended uses are met. With a mindset to “break the system” thereby identifying any d...

A successful validation process contributes significantly to assuring the medical device quality and proves that the product produced is fit for its intended use. Quality, safety, and efficacy are all...

A whole lot as been said but will like to add that Good meeting minutes help drive a plan of action for your leadership team and employees. Help in the structure and state ownership.

FDA looks for the following: The quality system: Processes and procedures define and implement to describe how the company addresses medical device regulations. Design History File (DHF): Demonstratio...