Are you a medical device manufacturer? According to the new Regulation (EC) 2017/745 on medical devices (MDR), medical device manufacturers must demonstrate to notified bodies that all critical suppliers conform with the ISO 13485 standard covering quality management...
Stents and other medical implants are products that have a high level of contact with the human body. As such, they are subject to strict regulations regarding their safety. If you are a manufacturer of stents or implants and want to market them in the EU, you will...
