I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, ...

This course has been very helpful in looking at some of the other areas of the medical device industry that I have not been exposed to. Not only that, but the interaction between other students with l...

Currently, I work for a company that employs the functional organization structure. This helps in allowing all the smaller specialized groups to focus on our certain tasks at any specific point of a p...

Hi, Looking at these different types, the last one in particular stands out to me for certain reasons. First, the fact that the directorate have an influential vision that is applied across the compan...

I have to agree with your suggestion of subscribing to a database rather than buying documents one off. This creates a much more sustainable business model for these organizations by ensuring that sub...

Fortunately I have had the opportunity to sit in on risk analysis session for a new product. The amount of time and effort that goes into creating the EURA’s (End User Risk Analysis) is very great. Th...

An interesting standpoint on design control is that they protect against product liability of design defect. Design defect is concerned with claiming the safety of the product is in doubt and that the...

I think its difficult to pinpoint a single portion of a DDP to be as the most crucial as all portions are critical to a project's success. To answer your question, a gantt chart is a very important in...

Yes, while a DHF is not needed for an EU release product, design controls are still an integral part of the process and are still integral. While that may be the case, I believe any company looking to...