Surfaces are everywhere, and we constantly come into contact with them. To live in this world means touching surfaces, so we rarely give it any thought. But the things that we manufacture that we come into contact with must be safe. This is true for everything we use or wear but especially so for medical devices.
Any medical device that comes into direct contact with people’s skin, blood or organs; or has indirect contact via contact with food or by conducting air or fluids that interact with people must be CE Certified to be marketed in the EU. Depending on their duration and type of body contact must undergo a physicochemical, morphological, and topographical (PMT) analysis, as defined by ISO 10993-19.
Correctly conducting a PMT analysis requires care and skill and is a critical step in ensuring product safety. Once completed, you will be better prepared to make well-informed decisions about your medical device and its readiness for the market.
SAXOCON has the expertise to help you get your medical devices compliant and certified for sale in the EU.
Check out how we can help here.