As Dr. Simon has mentioned in this week video lecture, method to analyze risks and one of the method he talked about is Failure Mode, Effects, and Criticality Analysis (FMECA). FMECA is potentially ut...

Design transfer is the process in which the device design is translated into production, distribution, and installation specification. Some of the common problem during Design transfer include • Produ...

Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing ...

Design input is the key point of medical device. If design input defined well during product development, it makes the rest of product development easier. Some sources state that establishing design i...

Design development plan(DDP) is a plan written by project manager, and it defines and describes all important aspects needed for the project. I think final scope statement is the most important part o...

Design control is required by FDA to check the medical device you design and develop is safe to use before you bring the product to market. Design Control is a procedure while developing a medical dev...