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 or from the company and a two way. Comapnies can ...

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 you have a good relationship with until you fundamen...

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, VPs of different functional groups but also of di...

I would agree with the matrix type organization as being very successful. It reduces redundancy and fosters working together to prevent re-inventing things that are required. Especially in medical dev...

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 many of its risks either removed or mitigated as muc...

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 documenting VOC (voice of customer), and testing our s...

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 work. In addition we miss holidays, forget to con...

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 purchasing the test. The engineer does make up the ...

Hi, I wanted to talk about something that come up occasionally at work. When I work on projects, I need to reference standards for various controls in the medical device market, like ISO, FDA, USP, AA...

The ISO14971 regulation directly involves Risk management. A few of the requirements are to have risks identified and documented, a risk management plan, and risk control. These can be in the form of ...

One thing, possibly less significant than many of the other suggestions here, is the difficulty in improving. If documentation is not done well and thoroughly from the beginning, it makes it difficult...

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