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...

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...

The purpose of the design and development plan section is to provide investors with a description of the product's design, chart its development within the context of production, marketing, and the co...

Clinical Trials are very essential both on medical devices and on drugs. The main purpose isn't to find the cure to all diseases. The main purpose of a clinical trial is to see how well the device or ...

The point about curing might be true in most of the cases .But clinical trials are not just about curing ,it is also about the safety of using the drug .In most cases it may not do the magic ,but it ...

Posted by: @bb254 If you were to have ownership of a corporation, which type of corporation would you want to be an owner of?a. Sole Proprietorshipb. Partnershipc. Limited Liability Partnershipd. Lim...

I very well agree with the previously mentioned posts that successful partnership can be formed based on the size of the business and number of people who wish to be the partners. Once the agreement a...

In short, there really is not a correct answer to this question. Although of course an influence, the type of corporation chosen will not determine if a business is going to be successful or not. Many...

When working on a brand new biomaterials which has never been used or made in medical device you will need to do all standard ISO (International Standard Organization) evaluating test which basically ...

Standard ISO 10993 testing which will help us determine the fitness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects.In orthopedi...

Hello All, This thread is a little bit of a surprise to me. I would have thought that the (RA) regulatory associate would be one of the most essential people in the entire group. It seems logical to ...

Companies hire FDA consultants before they're in trouble to ensure they set up their quality management systems (QMS) correctly. Organizations most commonly hire an FDA consultant when they're facing ...

I agree with you Jafar, I think it's a good idea to have RA (Regulatory Affairs) in the first meeting as well. Having input from RA could help prevent issues in the future of the project. I personally...

Industry research often has the benefit of short term results. With the goal of bringing a product or device to market, research is sought to be completed quickly. Long-term research can also be seen ...

It is hard to choose one over the other. Seeing the result right away give satisfaction for sure, but doing research that help the next generation might be like predicting the future. In addition, it ...