I think it makes perfect sense that there are rules and laws that prevent these things from continuing to happen. As Dr. Simon mentioned in this week's lecture, there are products out there that could...

NDA is not a substitute for a patent. Patents give you a solid proof of ownership of an idea or a product itself whereas an NDA is just a contract that is signed by two people who promise to keep thin...

This course was definitely beneficial in giving us an idea of what to expect when we go out into the real world. Dr. Simon did a good job in keeping us all engaged throughout the semester by asking us...

I agree with @jr377 that in order to move up to the upper level positions, you would have to be promoted from a middle level position. Similarly, in order to move up to the middle level position, you ...

There are advantages to each type so it's good to go over those first before you make a decision to be part of one. From a project manager's standpoint, functional structure gives you the least power....

We are planning on having weekly meetings to make sure everyone is on track. So far, we have completed the DID and DDP. Our project manager created a document where we wrote down the date we expect to...

When developing a new product or device, there is always a risk that things might go wrong. In order to effectively deal with and overcome these risks, companies need to come up with risk management p...

Risk-benefit assessment is the foundation for FDA's decision making process in terms of its medical device regulations. This assessment helps to determine whether the advantages a medical device bring...

Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying hazardous situations that may come up with the medic...

All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outputs. This means that your final product functions ...

I'm so glad that we have capstone as a required class. I think it would be really nice if we got to do a capstone project for each year that we are in college. That way we would have the opportunity t...

Design reviews are technical meetings held by a group of people who are working on the same project where the design for that particular project or product is evaluated against all of its requirements...

Establishing solid design inputs are essential to the success of a project. Each and every single requirement to a product needs to be clearly stated and understood by everyone working on that project...

Gantt chart allows you to create an outline of the tasks involved in a project and the time period in which those tasks need to be completed in order to finish the project on time. It gives you a visu...

Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets customer needs. In 1984, FDA identified lack of design co...