Last seen: Dec 1, 2019
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,...
Written agreements are preferable since parties can keep a record of them, they can be submitted as physical evidence in court during disputes, and cr...
There are several factors that need to taken into account when forming a Non-Disclosure Agreement. This agreement is meant to protect company informat...
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 impo...
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 be...
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 ma...
When selecting the method of risk management, I would take into account both the level of severity and occurrence. For high severity and high occurren...
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...
During risk management meetings, the project manager is in charge of facilitating the meeting and making sure that everyone's inputs are considered. T...
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 c...
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 achie...
Design verification is a required part of design controls regardless of the type of medical device, but the necessity for validation varies. Verificat...
If used appropriately, design controls can lead a company to design and produce a product that is a success in terms of effectiveness, marketability, ...
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 consisten...
Design controls consist of nine parts, all of which contribute to developing a final product that is innovative, effective, and safe to use. During th...