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 assessment may be needed if it changes the function of...

The essential differences are is that DMR contains all documentation for the design and manufacturing of the current product and all process are fully documented, while DHR contains all production/pr...

From my experience the tracking of medical devices in the post market surveliance often comes consumer feedback itself, we have a team that dedicates themselves to addressing potential issues. The add...

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 was going to be a very simple reform of a popular ta...

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 or at least have a pretty good idea on what it co...

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 consideration the budget limitation. This aspect is v...

Hi All, Currently I am updating a few SOPs, some of them are having a complete rewrites and the technology has drastically changed since its last revision. As a result, some of the SOP that I am writi...

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 finalizing the product. Such an example would be if we c...

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 working on. I am basically updating test methods for labo...

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 think about the concept of properly monitoring hea...

There already is a " right to try" legislation with regards to having experimental drugs given upon the request of a terminally ill patient. I attached two articles below that explains it. Chris

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 the market that have a minimal amount of impact on ...

As Fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specifications for the device and it does not take into conside...

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 its good to look back at historical data in order ...

By definition, verification evaulates whether or not product or system complies with a requirement, specification, or regulation, while validation assures that the product meets the needs of the custo...