A medical device I would consider to have significant risk, are contact lenses. Everyday millions of people (guessing, don't quote me), put contacts into their eyes instead of wearing glasses, but hav...

Merzkrashed makes a lot of good points. I think something else we would need to consider is the stockholders/team and customers/venders. Will your team agree with the decisions? Do they agree on the c...

I think cdj24 makes a really good point to think about the company. When thinking of how to answer, I was leaning more towards the idea of having a negative CV and a positive SV, as I think it would b...

Hopefully the project does not have to start over (maybe the reason why the PM had to leave), in which case the new PM would start from the beginning like every other time - as long as they know the c...

Where as it is obviously important for everyone involved to know the users needs, I also think it is important to consider what the user does not want. If we are given a list of things to include and ...

Going off of what srg36 said in response to moniquet07, I think the project scheduling would need a "Clarification" or a "Agreement" step. This way all parties know what they are up against, and if so...

This is a very interesting case to me. I honestly wouldn't know what to do. In my life though I have always found that honesty is a better policy. Releasing a product and banking on a placebo test is ...

The planning phase sets the foundation of how to complete the project. When this phase is not executed properly, then project could be terminated or not worth the money for funding. It’s a pain to go ...

I volunteered in a tissue engineering lab and we were working on trying to make a bio-ink with a decellularized pig heart. We had researched previous inks and composition models and did what we had to...

I think it depends on the device in question. While I think engineers are a key aspect of the building part and setting limitations on what can and cannot be done, when it comes to designing something...

Scope management is an important part of the company to inform the public and potential investors the projects description and heading. Its helpful for the company to have this timeline because they c...

This topic brings to mind the end of any commercial and how there is a long list of things that may happen based on their statistical analysis. For devices, their risks seem to incorporate an entire w...

I think we can all agree that the classification comes from the risk and novelty of the device. However when preparing my response for another forum post, I learned that this classification system was...

I think she is making a great point. Though I haven't read the book, from the sound of it I can see it has value. While funding and business needs the "easy" class system to report new devices, I thin...

I think this is interesting because I want to say that companies should go for it. For established companies, they would have ann easier time looking to the future and establishing new ideas than a co...