I think a reasonable location has to be somewhere where the main purpose is the meeting itself, with no other unrelated benefits. So places like meeting halls, restaurants or a hospital would be consi...

While there are a few things I would want to know before signing an NDA, I agree with other posters that they are not something to be avoided at all cost. I would be ok with signing as long as I know ...

The obvious reason for choosing a written contract over a verbal one is that verbal contracts are more challenging to defend or enforce in court, but another key advantage of written contracts is sett...

I think going above your management to senior management is usually a bad idea, and can engender negative work environments. If you believe as a manager you can implement certain techniques and proces...

I think keeping everyone talking and in communication can be a great benefit to a project team. Having a once a week meeting, even just for 30 minutes, where a rotating team member can give a short pr...

I think one person having decision making powers can be a bonus when kept to specific, time-limited scenarios. When the person making decisions has lots of experience and a clear idea of what needs to...

I think the greatest tool you have in this case is historical data. In most cases, unless your product is truly revolutionary, there should be at least a few devices that have gone through the entire ...

I don't think acceptance changes the probability of risk in a situation. I believe it just means that you are ok with that probability combined with the severity of a situation. This process was menti...

Learning about all the different fields in medical device development so far, I have seen a large overlap in responsibilities between the different teams like Design Control, Risk Management and Quali...

Literature research can be a big help in designing success criteria for a study. Looking at similar successfully released products can provide a great roadmap on defining what success means. This is i...

The Design Transfer Document is the answer to the first question. As long as all inputs/outputs are exhaustively documented, production errors should be kept to a minimum. Keeping a member or two of p...

Design minutes, while often ignored, I think are a very valuable tool. For one, they help to ensure accountability. If minutes are kept, they can always be referred back to if someone was given a resp...

Software validation is a great feature that can help in many ways. One big help is in customer satisfaction, if the software for a product works as expected and outputs the required information, less ...

As mentioned in the lecture, some companies do not take Design Control seriously, and instead create these documents as an afterthought, and just fit the already created methods into the required form...

While it is certainly possible to overdue it, I think logging more inputs then you think you will need is a smarter way to go then just logging the bare minimum. If failures start to occur in the devi...