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. If you sign a NDA with a company then they are obliged to honor…   Read more»

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 of settling a dispute and usually the first option. Negotiating can be conducted between the…   Read more»

As several people have mentioned I also was expecting the course to be more about specific medical devices rather than the whole industry process. However, I still really enjoyed this class and think it will be greatly beneficial for me…   Read more»

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 important than the relationship. Having a good relationship is beneficial for good communication…   Read 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 least two bosses; their functional manager and product manager. This helps a company…   Read more»

I believe it would be more difficult working as a project manager in the matrix based organization. There are three types of matrix based organizations. Functional matrix is when the functional manager has more power that the project manager, a…   Read more»

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 risks. The task analysis helps to identify and document the environment in which the…   Read more»

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 updated accordingly. Complaints and feedback from the users should be heard; the market…   Read more»

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 which is not only morally wrong but leads to huge lawsuits. It is…   Read more»

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. The business requirement document had us list all the costumer needs and make sure…   Read more»

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 to establish a good dosage range as well as collect data on the…   Read more»

As my classmates have mentioned the FDA does not demand specific tests for design verification or design validation. The FDA ensures good quality assurance practices with the 21 CFR Part 820.30 that Dr.Simon mentioned in his lecture. This regulation does…   Read more»

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 last audit because of the new ‘snapshots’. I think this method…   Read more»

I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product, or the FDA not allowing the product to get to the market. To add to all of this,…   Read more»

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. Therefore, all of the 5 parts you mentioned are important….   Read more»