Kohr Consultants

The core activity of KOHRconsultants is to advise and support companies in the medical device and IVD industry (In-Vitro Diagnostics) in fulfilling regulatory requirements and launching their products on the market. This includes in particular: The creation and review of technical documentation; The establishment of quality management systems (QMS) in accordance with ISO 13485, MDR, IVDR, 21 CFR 820 and GMP; Support for market launch in various countries and regions (D-A-CH, North America, Asia-Pacific, Brazil); The implementation of product registrations, including clinical trials and studies; Representation of companies as Authorized Representative in Switzerland and the EU.