I would say that it depends on the severity of the change, if its a major change that all documents should be adjusted and perhaps another safety asse...

The essential differences are is that DMR contains all documentation for the design and manufacturing of the current product and all process are fully...

From my experience the tracking of medical devices in the post market surveliance often comes consumer feedback itself, we have a team that dedicates ...

I had that happen to me when I was working in the consumer sector, I was reforming out of a ester that is now discontinued, it was believed that it wa...

Based on the information give, since the material has been in the development phase for a decade, the potential of the material should by now be known...

Hi All, I can definitely agree that a budget cut will effect the project, thus area that may have been clear may have to be reanalyze to take into co...

In my opinion an SOP, should be created to ensure repeatability of a process/ procedure. That being said it should be implemented when they are finali...

Hi All, Engineering change orders are an interesting and important topic. I am currently working on a few change orders for the CAPA that I am workin...

I completely agree with the comments above, the fitbit is not a medical device and it should not be liable to provide " accurate measurements" if you ...

There already is a " right to try" legislation with regards to having experimental drugs given upon the request of a terminally ill patient. I attache...

Great topic, as a the comment above me mentioned the FDA acts as a " Gate keeper"/ filter for consumers and ensures that good quality products reach t...

As Fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specification...

In my opinion I would consider the DHF to be a living document. Often times in a products life span there could be changes in materials/processes and ...

By definition, verification evaulates whether or not product or system complies with a requirement, specification, or regulation, while validation ass...