The implementation of the MDR presents many new challenges to medical device manufacturers. As a response to the new Medical Device Regulation introduced by the EU in 2017, Qserve designed a series of trainings
which focus on the fundamentals of the new MDR. These valuable training courses only touched on the fundamentals of the EU-MDR.
One year later, we have designed new training courses which will dive into specific MDR topics such as Economic Operator, Clinical Investigation, MDR Transition, how to write a Technical File, and PMS/PMCF.
Further additions to our program are In Vitro Diagnostics training courses. We have added these courses to assist IVD manufacturers so their current product files meet the new IVDR in 2022.
Quality Management Systems are also essential to compliance; therefore, we have created MDSAP Training and ISO 13485 basic and advanced courses.