EN ISO DIN 13485 is the main Quality System Standard for Medical Devices and In-Virto Medical Devices manufacturer to implement. This is the standard of choice to comply with the legal requirements in terms of fulfilling the CE marking requirements.

Most certainly other quality system standards may play a role for your company. MDSS, with its trained staff members, is well equipped to guide you through the quality system details. Our goal is to make the system work for you and ensure the minimum documentation with the most effective quality system. We are proud of our consitent project quality management.