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...
Do you manufacture reusable medical devices? If so, your products are likely used in medical facilities around the world. In the EU, manufacturers wanting to sell reusable medical devices must ensure that their cleaning, disinfection, and sterilisation procedures are...
Medical devices are often vital for a patient’s well-being and must therefore be safe and should definitely not worsen their condition. However, there is a high risk of particulate contamination for intravenous and infusion medical devices that can cause health issues...
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...
