Hi, I do agree with the above discussion, Risk severity is categorized into three levels and includes a duration component. The three levels are medical device-related deaths or serious injuries, medi...

Hi, I did some research and in my opinion the best way to address risks is pseudo-quantitative method is probably the risk matrix, which classifies the likelihood of a risk in one category and the con...

Hi, I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA's premarketing risk assessment is intended to identify and quantify risks d...

Hi, To complete a project successfully, you must control a large number of activities ,and ensure that they are completed on schedule. If you miss a deadline or finish a task out of sequence, there co...

Hi, A design review is a milestone within the product development process whereby a design is evaluated against its requirements in order to verify the outcomes of the previous activity and identify t...

Hi, I agree with the above discussion, following are the problem during design transfer. 1. The workflow of the manufacturing organization is disrupted by having to wait for released materials, proced...

Hi, Design input are one of the key point in design control.Design inputs mean the physical and performance characteristics of the device that are used as a bases for device design. The main procedure...

Hi, Design control are interrelated set of practices and procedures that are incorporated into the design and development process.A design control provides a systematic assessment of the design an int...

Hi, I agree with the above discussion . Design control is required for the EU release product .Actually DHF is used only before product release .Once the product is commercially released ,all changes ...