August 30, 2018
An Overview of Common Gaps in Clinical Evaluation Reports (CERs) and Technical Documentation Under the MDR
Among the many daily activities performed by a medical device manufacturer, uniform compliance to the MDR for technical documentation is an especially time-consuming challenge. At Qserve Group, we are here to help analyze and identify a wide array of potential gaps across Clinical Evaluation reports, as well as technical documentation (such as Design Dossiers and Technical Files). An awareness of potential compliance gaps is an important first step towards planning a pathway to MDR compliance.