An NDA is a contract that is a matter of state law, where a patent is a federal document, and therefore, interpreted uniformly throughout the country....
I believe you mentioned the two biggest methods but another method out of court dispute resolution is just negotiating. This is the most basic means o...
As several people have mentioned I also was expecting the course to be more about specific medical devices rather than the whole industry process. How...
As mentioned, the privilege of picking one's ideal team is not always an option. If one does have a choice though, knowledge in the department is more...
I believe the matrix org structure would be the best for most companies. It provides a well balanced structure as the employees have to report to at l...
I believe it would be more difficult working as a project manager in the matrix based organization. There are three types of matrix based organization...
I agree with all of the methods mentioned but I believe the task analysis and error use analysis methodology is the best way to address usability risk...
I believe one of the most important mistakes mentioned was how risk management is not a life cycle process. It should be a living a document and updat...
For high severity of risk I would use mitigation and avoidance. A device with a high severity risk has the potential to kill or severely harm someone ...
I also had to do a business requirement document in capstone here at NJIT and I see the similarities between this and the design validation process. T...
Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase...
As my classmates have mentioned the FDA does not demand specific tests for design verification or design validation. The FDA ensures good quality assu...
AS sdl3 said, the Design Dossier or Tech File can be beneficial for audits as they only have to look back at the material that was updated since the ...
I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product,...
As Dr. Simon said, the DDP is often just used as a boiler plate placeholder in the DHF but it should be used as an underlying plan for the project. Th...