During this unprecedented time, we wish to extend our heartfelt prayers for health and safety to our global client community, and let you know that our thoughts go out to everyone impacted by the pandemic.
Here at Nerac, we have taken significant steps to achieve the advised “social distancing” recommendation by our Center for Disease Control, and to limit exposure to COVID-19. We are closely monitoring updates from the CDC and the World Health Organization regarding the virus. We will continue to seek guidance from these agencies, public health officials and government agencies on an ongoing basis.
In the same way that a major motion picture is planned and storyboarded over a period of years, the Clinical Evaluation Plan (CEP) of the Medical Device Regulation 2017/745 (MDR)1 is designed to do the same. The CEP builds a “storyboard” that explains how that device will meet the need and lays out a plan to show it.