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 others, and it is not easily enforceable.

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 apply to the agreement.

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 it was a big…   Read more»

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 happy…   Read more»

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 different type of projects and also more soft…   Read more»

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 time and having a good (Friendly) relation…   Read more»

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 bars represents the frequency…   Read more»

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 greater…   Read more»

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 field, detecting product faults, and help initiating necessary measures such as recalls…   Read more»

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 requirements by giving more attention to…   Read more»

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 and regulatory input. During the project…   Read more»

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, the shear valve segmentation of…   Read more»

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 device coming from other…   Read more»

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 best example for it. -…   Read more»

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  immeasurable variables that may lead to biased and incorrect estimate of…   Read more»

one thing to add is clinical trails for drugs takes at least 10 years to develop new medicine. It take a lot o time for development and getting FDA for approval. I have red and i am quoting “Less than…   Read more»

As have been said before there is different Pros and cons for clinical studies, one of the cons that come up to my mind is long term side effect. Some side effects appears several years later even after clinical trials…   Read more»