Preparing your QMS for the EU MDR
Current MDR Status Medical Device companies selling devices to the EU are already preparing to re-certify their products (all classes)
Current MDR Status Medical Device companies selling devices to the EU are already preparing to re-certify their products (all classes)
CHALLENGE: Following an audit conducted in a Medical Device Company, it became apparent that the Device History Record (DHR) release
Commercializing medical technology is challenging, often requiring 10 – 20 years just to bring new ideas to market. There is
You have a medical device product that has been on the market for a short period of time with FDA
NanoSono nanomaterials technology transforms almost any medical device, fabric, filters, or any type of surfaces into an antibacterial surface and
Challenge: In order to obtain CE mark certification for an innovative medical device, the Medical Device company was required to