I agree with those who said that SOPs are not needed for the research phase of a project. It is important to remember that SOPs are very specific, det...

Most of the posts above state that the SOP should be a very detailed document, and I agree with that as well, but I also like the comments made about ...

I have sat in on and been an active participant in many design review meetings in my company, and I would like to comment to djr32 that although it ma...

From my experience there is not necessarily a risk/benefit ratio, but rather the company performs an analysis where they weigh all the risks and compa...

If I were a PM running a risk management meeting, I would first create a timeline of events with my team from the time the device is shipped out of th...

In medical device projects that I have worked on and am working on, one of our most important external stakeholders are our suppliers. We do not do an...

The purpose of an ECO is to provide a framework for making a change to a product once it is already released to the market. Going through the ECO proc...

I agree with the above posts regarding the strategies used in post market surveillance (PMS) as well as the benefits obtained from doing PMS. I would ...

Packaging development is a very important part of a medical device project, and in my company, we have engineers who are dedicated to package developm...

I agree that choosing the right project team is a very important part of the project initiation phase. However, in almost any team, there will probabl...

I agree that it is important to have a good plan of how to handle testing failures when doing your V&V, but I like the points that @gh56, @merzkra...

The school of thought that says that the DHF is sealed at the end of Design Transfer is most appealing to me, and that is the school of thought that m...