I worked in the software development area. Our company would call it the Engineering Change Order for Code Change. There were many change orders depending on whether it was an addition to the code, or...

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 added to any kind of ECO. Therefore, an ECO is revie...

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 SOP's should be written during research phase. In...

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 logical to me. For those of you who are currently w...

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 documentation and therefore it is a requirement by the ...

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. Technically, DHF is put together initially when the product ...

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 classified as a Class III device in the US where as ...

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 clinical evaluation report. It is an essential require...

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 submitted regardless of where the medical device is...

In one of the first week's lectures, Dr. Simon talked about the the Four P's of Marketing: Product, Price, Promotion, and Placement. In addition, he mentioned the fifth P- Participation. If you who w...

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 their own technology experts/consultants to provid...

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 establishing a product's regulatory and product dev...

As we learned in the lecture that contract laws are the basis of doing business in other countries and some nations have stronger contract laws than others. Since many companies want to invest or star...

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 cases where my client wanted to hire an employee w...

NDA usually excludes the information that is publicly available or information that was already made available to the recipient prior to its disclosure. It also excludes information which was obtained...