With the European Medical Devices Regulation (MDR) compliance a dominant topic at the Medica 2019 medical tradeshow in Düsseldorf, Germany, Emergo by UL consultants in attendance have presented an MDR readiness checklist whereby manufacturers can gauge their preparedness for the new Regulation.
Oliver Eikenberg, Ph. D., Senior RA/QA Consultant at Emergo by UL, discussed key elements of MDR compliance identified in the checklist (PDF download) during the Tech Forum component of the tradeshow.
“Identify your key concerns,” Eikenberg told the audience. “What are critical compliance aspects that need immediate attention? We only have six months left, and many companies have not started.”..