Are you using 3D printers to produce mock-ups or in manufacturing? What kind and how many particles are produced while using a 3D printer? Particles produced during 3D printing pose a health risk. In fact, they are almost as harmful as the exhaust produced by Diesel...
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...
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...
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...
As of today, 5 January 2021, all suppliers of physical products in the EU market are required to track and report the content of substances of very high concern (SVHC). This information shall be made available to consumers and waste operators by filling in the...
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...
