Last seen: Nov 27, 2019
A patent gives the company legal ownership of an idea or design. This allows for the owner of the patent to have exclusive ownership of the idea or de...
I have had two jobs where a non-compete clause in my employment agreement. The first one had clause where I could not work for a competitor within a c...
When forming a project team, I think it would be best to be able to assemble a team of people who have worked together before and have shown to be abl...
In my opinion, I think that matrix organizations are the most effective types of organizations. Since employees are still part of a functional departm...
The organization that I work for would be considered a matrix organization. People are organized by department, and project teams are creating by taki...
Post-market surveillance is now required by the FDA. Med device companies must have tracking systems in place, report medical device malfunctions, inj...
In agreement with some of the replies above, some residual risk is acceptable if it is necessary for the function of the device. In these cases, it is...
In my experience, FMEA has been the most beneficial tool to use for risk management. Every product in my company has a D(esign)FMEA and a P(rocess)FME...
Tests used for design verification must be able to demonstrate that a particular characteristic of the medical device is conforming to the specificati...
Design Verification testing for any medical device will demonstrate that the product meets all of the specifications listed out in the DSD/Product Spe...
In my experience there are three parts to process validation: the Installation Qualification (IQ), an Operation Qualification (OQ), and a Process Qual...
In my experience in design review meetings, it is important to be well prepared. Depending on the phase of the design review, the person leading the m...
As an R&D Engineer, I work with a lot of the types of documents that were described in this weeks lecture. For our Design Input Document (DID) we ...
When a deviation occurs in a protocol due to a failure, it is often required to investigate the reason why the failure occurred. This investigation is...