As stated here, there is a pretty big difference between an NDA/ CDA and a patent. There are also a few versions of NDA/CDAs, a one way to the company...

This is a tough question since you don't always get a say in who is available to work with. But as a general rule, it is easier to work with people yo...

I think my organization is a matrix type, but it also falls into a few othe categories from the website that another classmate posted We have a CEO, ...

I would agree with the matrix type organization as being very successful. It reduces redundancy and fosters working together to prevent re-inventing t...

This website explains this concept of AFAP and something else called "As Low As Reasonably Practicable” (ALARP). The idea is that the device has as ma...

I work in Sustaining Engineering and though we don't usually come up with new products and develop them, we do put a lot of work into getting and docu...

I agree as well. We have had many issues with timelines being unrealistic becasue they are set from above instead of by the people actually doing the...

To your point, the ASTM and ISO standard test methods are very relevant to this question. They also can be modified for different applications after p...

The ISO14971 regulation directly involves Risk management. A few of the requirements are to have risks identified and documented, a risk management pl...

One thing, possibly less significant than many of the other suggestions here, is the difficulty in improving. If documentation is not done well and th...

Coming from the "Continuous Improvement" mindset, I would think that the "snapshot" that EU regulatory bodies focus on is really only from a practical...