Carmeda has extensive experience in bringing our coating technologies to new devices, through regulatory approval, and onto the market. We know how to get your coated product approved and we will assist you all the way.
Carmeda is a streamlined, project-driven organization, which ensures a smooth process for feasibility studies, product development, and production projects.
Essential tools in our work are efficient design control and project management systems. In addition, formal proactive risk analysis is integrated at an early stage in our projects and is revisited throughout the development process.
Carmeda has a Master File available at the FDA, which will facilitate the regulatory process for new applications in the USA.