Companies should always have their employers and vendors sign a non-compete agreement and a non-disclosure contract. Some of the trade secrets limitation to be considered is that it can be patented by...

One important thing to be aware of, especially when dealing with companies from other counties, is to understand how there system works treating the NDA . Always clarify which jurisdiction you wish to...

Having this rule is really helpful, as the physician will not make the judgment about the device according to what the company has offered from gifts, so the process will be fair to all companies if i...

After the team has meet, we did brainstorming for getting all DID inputs and even Risks, Our PM did the planing and the timeline and we are working to get everything done according to the Gantt chart....

I am currently working in a functional organization outside of the biomedical field. I would like to work i a matrix organization because that can let me gain different experience working in differen...

Having a knowledgeable team members with a good relation is the best combination. With there knowledge in there department will help them understand there roles and what they need to deliver on what ...

In addition to what the others have said, Pareto diagram is a great way to identify which problems should be prioritized based on the cumulative effect it has on a system. While the length of the bar...

As we all know, X-ray devices have a lot of risks if the person was expose to high radiation levels, but having the X-ray was huge deal in the medical history. Some risks we need to accept for the gre...

Post-market surveillance is important because it reveals more about product safety and effectiveness that could not be learned during clinical trials. It also monitor products' performance in the fiel...

One of the most important thing to have deign controls is to reduce the products recall and to save more humans. It also to assure that devices meet user needs, intended uses, and specified requiremen...

As it have been stated by the others, DID is a document that contain the inputs data from the customer (users) but it also have different inputs such as Functional, environmental, physical , labeling ...

Abbott Cell-Dyn (CBC instruments) verification protocol should have to test the amount of blood the syringe take in from the tube in both open and closed mode, the time it take to give the results, th...

I did a search about Jordan regulation and i really found it interesting. As it is a small country, i did not found anything about development of medical devices, but all the regulation are based on d...

All the 9 are very important, but you can still find projects done without some of them. - Planning should have breakdown of tasks alongside the people/team responsible for them, a Gantt chart is the ...

Randomization and blinding are considered to be characters of best study design, but the "Gold Standard" Clinical trial are Randomized double blind placebo control. It eliminate the influence of imme...