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...
The EU is conditionally extending the MDR deadline. Medical device manufacturers with certificates approved before 26 May 2021 can extend their validity if their products meet certain conditions, one of which is the establishment of an MDR-compliant Quality Management...
According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that their selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These...
Exposure to aerosols can negatively affect health. Using our SAXOCON Impactor tool, we can determine what is in the air at your workplace, if there are any risks, and how to mitigate potential problems. We designed and built the SAXOCON Impactor to be a highly...
Do you know what airborne particles you are exposed to and which of these particles is a health concern? We can help you determine what is in the air you are breathing, the risks posed, and how to mitigate potential problems. Using the method improved at DTU Nanolab,...
Are you a medical device manufacturer? According to the new Regulation (EC) 2017/745 on medical devices (MDR), medical device manufacturers must demonstrate to notified bodies that all critical suppliers conform with the ISO 13485 standard covering quality management...
