Design review meeting is a technical meeting that is held at the early stage of the project. A design review generally involves a presentation of a planned design, at a time early enough in the process to allow for changes…   Read more»

Obviously, I think all parts of the DDP are essential. If they were not, by now they would likely be obsolete. However, out of all of them, I agree, the Communication management is the most essential aspect. Communication is key…   Read more»

Design Controls are important for any product development project. However, just any Design Controls thrown together haphazardly and insufficiently will not suffice. Design Controls are the blueprints and building blocks fro everything else in the product development process.  Design controls…   Read more»

Verification tells a company that the developed device meets the requirements for the product. This is done through tests and a lot of analysis, which are operations that cost companies money to perform. What makes it worth that money (besides…   Read more»

Design controls are required by the FDA pretty much to ensure the developed device is safe for public use. While the company has to spend resources to create design controls, it also structures the development process and gives the company…   Read more»

The Design Input Document is the foundation of any product development project. It contains the basic functionality requirements and details of the product. Because of the amount of information that needs to be in the Design Input Document, there are…   Read more»

Design inputs can greatly affect the functionality of a device. Therefore, one of the greatest factors in design inputs are the device’s functions. The design inputs have to comply with the requirements of the device. For example, a computer mouse…   Read more»

Design inputs are the foundation of a medical device. Solid Design inputs makes the rest of medical device product development easier too. Design input should not just be the responsibility of one person. it is a team effort. when a…   Read more»

Design control are intended to demonstrate that a medical device has been designed to address the needs of users and patients.       Design input : This define the performance criteria and feature requirement of medical device. Design input…   Read more»

Design control designates the application of a formal methodology to the conduct of product development activities. Design verification confirming that the design output meets the design input requirements so we can detect if we design the device right or no?….   Read more»

I would like to be a clinical research assistant and be in close connection with the investigation, reason being,  I personally like core biology a lot and it interests me to go in depth into the investigation and know the…   Read more»

For PCT I would say it depends upon the type of trial being under consideration I think they are pretty good to go with in terms are being ethical, as there is low risk and patients might get cured on…   Read more»

I personally think that clinical studies are necessary as we need to test it on humans to actually know what the results could be human, because the other way would be not to have a trial at all and then…   Read more»

There is no complete correspondence between animal testing and humans.Doing tests on tissue apart from a live person is not always possible.So there is no way to get conclusive results wi

Verification is an immensely important step in the medical device development life cycle. A deviation is essentially when a technician is forced (or mistakenly) deviates away from the test protocol which could be caused by anything from unexpected outcomes of…   Read more»

While working for industry, a gantt chart is a very powerful tool to lay down hard deadlines and the structure of a project. Tasks and sub-tasks are to be laid out and an estimate of how much time each of…   Read more»

Any job in the world does not require previous experience to be good at. The main advantage for people who are hiring is that if someone has previous experience the time required for them to train them decreases significantly. Also,…   Read more»

I think consent should by all means be secured from patient prior to using materials or data from patients. It is crucial people and therefore patient have complete control over being. At the core of slavery of African for several…   Read more»

A double blind study help to eliminate bias of doctors participating. It is within the realm possibility to have a doctor whom may be willing to influence a study out come for monetary gain. The doctor could have accessed to…   Read more»

Placebo is being used extensively in the field of pharmaceutical clinical trials. It is important to acknowledge that the extent of how the human mind places a role in affecting the human body both positively and negatively. And the only…   Read more»