I worked in the software development area. Our company would call it the Engineering Change Order for Code Change. There were many change orders depen...

The change process is really when someone identifies an issue that may need to be addressed. In agreement to the post above, there is a cost factor ad...

SOP is basically a step by step instructions document compiled so that the workers can carry out a complex routine efficiently. I definitely think the...

A follow-up question from Dr. Simon's post: As I mentioned earlier, once the DHF is sealed any ongoing changes should be added to the DMR seems more ...

The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls docum...

In my opinion, the first thought where the DHF is sealed and any updates after the design transfer are added to the DMR seems more logical. Technicall...

I was able to find one example of where the classification of a device was different in the EU vs the US. Contraceptives such as a female condom is cl...

Another difference between 510k and a technical file is the submission of a clinical evaluation report. All devices with a CE marking must have a clin...

One of the main differences between 510k and a technical file is the risk management file. Although, ISO 14971 requires a risk management file to be s...

I used to work for an IT firm where I was assigned to a client that used to focus on VR for physical rehabilitation. Earlier, that company was hiring ...

I have not had an experience working with PMOA for a combination device yet. Upon some researching, I have found out that PMOA is very critical when e...

In my personal experience, I also had to sign a non-compete during on boarding which restricts me from working at certain companies. I have witnessed ...

NDA usually excludes the information that is publicly available or information that was already made available to the recipient prior to its disclosur...