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'...
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 tha...
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 u...
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 o...
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 standpoin...
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 ...
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...
Risk-benefit assessment is the foundation for FDA's decision making process in terms of its medical device regulations. This assessment helps to deter...
Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying ha...
All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outp...
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...
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 pr...
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 ...
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 ...
Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets custome...