CH-REP Manual for Switzerland

Description

For Swiss authorised representatives (CH-REP) of manufacturers outside Switzerland of medical devices on the Swiss market. It is suitable for CH-REPs with and without a certified quality management system (QMS). This manual describes all activities related to your CH-REP role including the PRRC (person responsible for regulatory compliance) according to MepV and MDR. It contains the full requirements and their implementation and is easy to adapt to your situation. It is therefore not only very helpful internally and for training purposes but is also very well suited for supporting audits by Swissmedic or your customers.