Surfaces are everywhere, and we constantly come into contact with them. To live in this world means touching surfaces, so we rarely give it any thought. But, the things we manufacture, the things we wear on or have implanted in our bodies that we come into contact...
Do you use nanomaterials in your production processes, or are they in your final finished product? If so, you are subject to EU regulations that require you to know and document your use of nanomaterials. According to ECHA, products incorporating or consisting of...
Whether you are manufacturing medical devices, pharmaceuticals or combination products, you will be using materials. Marketing your products in the EU requires that you ensure the quality and safety of the materials used in your products. Early and robust material...
Surfaces are everywhere, and we constantly come into contact with them. To live in this world means touching surfaces, so we rarely give it any thought. But the things that we manufacture that we come into contact with must be safe. This is true for everything we use...
Download our white paper on nanomaterials today! The new EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR) do include specific classification rules for devices that consist of or incorporate nanomaterials. For medical device manufacturers, it is important...
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...