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...
SAXOCON is ready for the EU MDR, are you? 26 May 2021 is the deadline for the full implementation of the new EU MDR (Medical Device Regulation). This will have far-reaching consequences for all medical device manufacturers that want to sell their products in the...
In order to market a medical device in the EU, a CE Mark certificate is needed. This certificate verifies that the product is safe and performs as intended. The ISO 18562-1 standard prescribes a process for testing and documenting the biological safety of the gas...
SAXOCON can test and identify nanomaterials based on EC definitions. Let us help you find out if the materials in your portfolio are, or contain, “nano” and to ensure that they meet all relevant regulatory requirements. Check out our analytical services...
EFSA announced changes to the evaluation of food enzymes compiled in a joint dossier in March 2020. If you are part of a joint dossier on food enzymes you may need advice for your toxicological study strategy. SAXOCON’s highly skilled toxicologists can help you in...
