In terms of the how risk is prioritzied in my company, an assessment is made on the impact of the risk (monetary, time, liability, etc.) If the issue is one deemed high risk (will cost much money, and...

search what is residual risk? Definition and meaning in google to find article by MBN

At the end of the day, it seems that there will always be residual risk that a medical device company will have to deal with. The measures that companies take will not be guaranteed to completely elim...

To find the video search The $40 Internationally Standard Cup of Tea

This topic reminds me of a somewhat comical video that I had watched a while ago Similar to what is being talked about, this video gives an overview of standardization and how it is something that is ...

Not having good design controls can definitely cause product failures as mentioned above. If design controls are not used properly, users of products may use it and cause great harm to themselves or t...

More information contained here (referencing my earlier post)

In a DHF, all the documentation that went into preparing a product and designing it is contained. It contains all the neccessary documentation and proof that a product was made within spec of what was...

While I have not been able to attend design review meetings as my job function doesn't include doing so, I have had interactions from the results of a design review meeting. Once a design review meeti...

As many have said above, having meeting minutes that clearly document what was talked about and the action items that arose as a result is crucial. These minutes are essentially a snapshot of the meet...

Within my own experience with Gantt Charts in industry, as others have said, it is a tool to help keep a project on track. It outlines the necessary steps that need to be taken, and the sequences they...

The DID and DSD are both necessary in their own right as they can be meant for different audiences and purposes. DID's basically outline the high level overview of what the product is going to be like...

I found the same thing when I was working with my Capstone Project here at NJIT. Our team was looking into the possibility of patenting our device, so we looked into the different rules surrounding th...

Overall, double-blind studies are not meant to increase some sort of significance to the investigator, but is more about collecting good data that is not tainted. In single blind studies, there is cha...

Right to Try seems to be a good step in terms of validating the drugs that companies make, assuming that it continues to use the "compassionate use" case in order to decide who gets these drugs. For p...