ATZ Healthcare AG

The core activity of ATZ Healthcare AG is to provide services to medical device manufacturers to support them in complying with regulatory requirements in the European Union and Switzerland. This includes, in particular: acting as an authorized representative (EC REP) for foreign manufacturers to market their medical devices in the EU; assuming the role of a Responsible Person for Regulatory Compliance (PRRC) in accordance with Article 15 MDR; supporting the registration of medical devices in the EU and Switzerland; verifying and monitoring the conformity of medical devices with relevant regulations; and representing manufacturers before authorities and cooperating in corrective actions and product testing.