Stents and other medical implants are products that have a high level of contact with the human body. As such, they are subject to strict regulations regarding their safety. If you are a manufacturer of stents or implants and want to market them in the EU, you will...
Reusable medical devices are ubiquitous and necessary tools for medical facilities around the world. As a manufacturer of reusable medical devices who wants to sell them in the EU, you will need to ensure that your cleaning, disinfection, and sterilisation procedures...
Are your production equipment and systems qualified for product contact? On Wednesday 13 January 2021 from 15:00 – 16:30, we will be hosting a webinar on the role and design of extraction studies to ensure safety and quality in pharmaceutical manufacture. Programme:...
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...
In order to market a medical device in the EU, a CE Mark certificate is needed. This certificate verifies that the product is safe and performs as intended. The ISO 18562-1 standard prescribes a process for testing and documenting the biological safety of the gas...
