Do you manufacture reusable medical devices? If so, your products are likely used in medical facilities around the world. In the EU, manufacturers wanting to sell reusable medical devices must ensure that their cleaning, disinfection, and sterilisation procedures are...
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...
Reusable medical devices are ubiquitous and necessary tools for medical facilities around the world. As a manufacturer of reusable medical devices who wants to sell them in the EU, you will need to ensure that your cleaning, disinfection, and sterilisation procedures...