ISO 10993-1 is the foundational standard for the biological evaluation of medical devices within a risk management process. It specifies the general principles for assessing the biological safety of medical devices that come into contact with the body. The latest...
SAXOCON provides microscopic particle count testing in accordance with Method 2 in USP-NF (788). Testing is conducted in our Class N2 clean workspace according to our internal protocols to guarantee the precise identification and measurement of particles that satisfy...
Pharmaceutical and medical device manufacturers need to ensure the safety of the materials used in their products. Particulate contamination is a risk in production facilities. Good Manufacturing Practice (GMP) and proper risk management require the identification of...
Last fall, the European Chemicals Agency (ECHA) won a decisive judgement at the European Court of Justice. This judgement allows the ECHA to classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT),...
Medical device manufacturers must ensure the biosafety of their medical implant products to comply with relevant regulations. Medical implants have intimate contact with the human body for durations lasting a few hours to permanently. As such, they are subject to...
Whether you are a pharmaceutical or medical device manufacturer, you need to comply with several layers of guidelines and regulations to bring your products to market and keep them there. Having suppliers you can trust is crucial to your ability to concentrate on...
