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...
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...
March 31st is the deadline for the completing your step 1 risk evaluation on potential nitrosamine impurities in medical products. These highly toxic compounds, some of which are considered to be even more carcinogenic than currently established thresholds, are...
Do you manufacture an in vitro diagnostic medical device? If so, you will need a CE Mark certificate to market it in the EU. A CE certificate verifies that a product is safe and performs as intended. The regulation, (EU) 2017/746 (IVDR) Annex I, prescribes general...
The FDA is updating their current thinking regarding the type of biocompatibility information needed for certain devices made from common polymers and fabrics that are in contact with intact skin. Read more about the new FDA Guidance here. SAXOCON can help you pick...
