Design Controls for Medical Devices

Design Controls for Medical Devices

Design Controls indicate that the medical devices your company makes are both safe and efficacious for the end-users. Let us say that your R&D department has come with a brilliant idea for a knee implant that will eliminate the disadvantages of currently available...
Medical Device Classification Guide

Medical Device Classification Guide

If you are a manufacturer of medical devices and plan to market your product in either the US or EU markets, you must classify your medical device according to the edicts of the respective regulatory agency. The purpose of classifying your medical device is to...