SAXOCON congratulates Arla Foods Ingredients on the positive EFSA opinion regarding their novel food application for Lacroprodan® BLG-100. We are proud that our contribution helped get the application over the finish line and look forward to Arla receiving full EU...
We are on the verge to merge. Things in the regulatory space for medical device manufacturers are about to get easier. In a new proposal on Quality System Regulation Amendments for Medical Devices, The FDA has decided to harmonize their GMP requirement for medical...
Packaging is not the first thing we think of when we think of food. However, the biosafety of the materials used in food packaging impact the food contained within. So, it is essential to understand the health and safety consequences of the packaging. For more...
Do you manufacture in-vitro diagnostic medical devices? If so, you will need a CE Mark certificate to market them in the EU. A CE certificate verifies the biosafety of your products and that they perform as intended. Regulations such as (EU) 2017/746 (IVDR) Annex I...
To know your materials is the beginning of wisdom. One key aspect of manufacturing is materials screening. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with your materials throughout your supply...
Ensuring the biosafety of your medical implants is necessary for getting them in compliance with relevant regulations. Medical implants come into intimate contact with the human body for periods lasting from a few hours to permanently. As such, they are subject to...
