MDSS

MDSS (Medical Device Safety Service) GmbH is a leading authorized representative and regulatory consulting organization for medical device and in vitro diagnostic manufacturers worldwide, established in 1994 and headquartered in Hannover, Germany. The company acts as the official regulatory point of contact for clients with the European Commission, national competent authorities, MHRA, Swissmedic, TGA, Medsafe, and the FDA, enabling non-EU manufacturers to access and maintain compliance in European, UK, Swiss, US, Australian, and New Zealand markets. MDSS serves clients across the medical device and IVD industries with over 30 years of regulatory expertise, covering product registration, vigilance, incident reporting, and conformity assessment.