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 academia, an NDA can allow researchers to present t...

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 you to discuss information without worrying about l...

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 applies to the real world. I learned a lot about med...

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 column on the side for comments. We had a week to ...

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 detail orientated. I feel that these two qualities woul...

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 and project group. You also have two managers, one ...

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 with the use of the device can receive a low index nu...

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 produces a false-positive result, the patient woul...

ISO 14971 requires a specific risk management process for medical device companies to follow. The major phases are risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit ...

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 suggestions from surgeons and other medical practitioners....

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 components to the timeline. Often, only hard deadlines su...

Often times the case of insufficient design controls is actually the failure to establish good document management. The success of a medical device depends largely on its foundation. Good document man...

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 these inputs must be addressed and included in th...

Design controls are to demonstrate that a product completes the user needs, meets inputs and requirements, is proven to meet the standards, and meets the performance criteria. The FDA clauses for Desi...

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 needs (validation) and that the device functions as i...