Are your production equipment and systems qualified for product contact? On Wednesday 13 January 2021 from 15:00 – 16:30, we will be hosting a webinar on the role and design of extraction studies to ensure safety and quality in pharmaceutical manufacture. Programme:...
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...
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...
