With what the original post had mentioned, I agree that both the Gantt Chart and Network Diagram are necessary for project teams to have. There are a ...

As the original post mentioned, I also have not ventured into a device development job. I think functional organization is the “worst” one for me to s...

I would say that the most applicable development strategies would be evaluation, analysis, and adjustment. They would evaluate the current situation o...

As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companie...

There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was ...

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These ...

As most users have said here, yes, I do feel safer knowing that medical devices include verification and validation testing. That goes to show that th...

I do think that these 4 columns are enough information in a design matrix. Design inputs, design specifications, verification, and validation are the ...

I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of t...

Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps t...

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or c...

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for...

Artificial intelligence has been up on the rise as of recent years, but it seems to be slowly taking over this past year. I have not seen this much us...

Clinical experiments require human testing and this is usually done after preclinical trials have passed in animals and are deemed safe to perform on ...

Reading all of the responses, I would like to disagree that the placebo effect cannot have any negative effects on a clinical trial. I think that plac...