The amount of information included in an NDA can vary from project to project. It also largely depends on why the information needs to be shared. In a...
I think an NDA can facilitate the road to obtaining a patent. An NDA can help protect the idea from getting into the wrong hands, and legally allows y...
This course was really informational above all. The lectures did a good job of explaining everything and the discussions made it easy to see how it ap...
We have a Google drive folder set up that everyone has access to. Our PM uploaded each document and also created a rough draft of the DID which had a ...
I think I would prefer to work in middle management because I would want to be more involved in the project. I like to think critically and I am detai...
I think I would prefer a matrix organization while working on a project. In a matrix organization you are a part of two groups, the functional group a...
An important factor of determining the value of the risk index is the tolerability of the risk. Often low risks such as mild discomfort associated wit...
One risk-benefit factor to consider is how false-positive or false-negative results would affect the patient. In the case of a diagnostic device that ...
ISO 14971 requires a specific risk management process for medical device companies to follow. The major phases are risk analysis, risk evaluation, ris...
Often it is not the end user that is the source of design input. Especially for medical devices, more technical design inputs are inspired by suggesti...
Gantt charts are used to plan projects using long term and short term deadlines. In my experience it is important to incorporate both of these compone...
Often times the case of insufficient design controls is actually the failure to establish good document management. The success of a medical device de...
The purpose of the design input document is to define each user need as an objective and measurable design input. While developing the product each of...
Design controls are to demonstrate that a product completes the user needs, meets inputs and requirements, is proven to meet the standards, and meets ...
If there is sufficient evidence already available for a similar device, V&V will only be necessary to make sure that the device meets the user nee...