I personally felt that this course was very helpful to me, since it provided me with more insight into all the steps required to develop, manufacture, and release a medical device. It was interesting ...

Written agreements are preferable since parties can keep a record of them, they can be submitted as physical evidence in court during disputes, and create a situation where it will be more difficult f...

There are several factors that need to taken into account when forming a Non-Disclosure Agreement. This agreement is meant to protect company information such as, trade secrets, client information, th...

If given the opportunity to choose my team members, I would go for members who are knowledgeable and experts in certain departmental roles. It is important that each departmental role is appropriately...

I would prefer to work in a strong matrix organization, where balance of power between the project managers and functional heads are less skewed. I believe this type of organization is best, since it ...

I agree with some of these posts in that I would like to start with middle management and possibly transition into upper management later on. Upper management is strategic in looking at the big pictur...

When selecting the method of risk management, I would take into account both the level of severity and occurrence. For high severity and high occurrence risks, I would definitely choose avoidance sinc...

Since it is impossible for the company to predict what every person using their product will do, the team should always reduce or completely eliminate the possibility and level of harm before they pla...

During risk management meetings, the project manager is in charge of facilitating the meeting and making sure that everyone's inputs are considered. The team will identify the risk, calculate the prob...

While including all of these parts of the DDP is best practice, I would choose scope management plan and communications management plans as the most crucial. A well designed scope management plan will...

The DID contains the desired inputs of the product. These inputs are more general, but provides all departments a rough idea of what needs to be achieved. The marketing department plays a major role i...

Design verification is a required part of design controls regardless of the type of medical device, but the necessity for validation varies. Verification and validation both take outputs into account,...

If used appropriately, design controls can lead a company to design and produce a product that is a success in terms of effectiveness, marketability, safety, and revenue generation. However, misuse or...

Verification is an important part of design controls since it ensures that the inputs match the outputs. It is a way to test the quality and consistency the products, making sure that all the design f...

Design controls consist of nine parts, all of which contribute to developing a final product that is innovative, effective, and safe to use. During the planning phase, the project proposal gives manag...