New to EU MDR?

? New to #MDR? Here are the critical elements in layman's terms :) ☑️ #ISO13485 #QMS - So you can consistently design and manufacture your medical devices based on requirements. ☑️ #PMS - So you can analyze post-certification/market safety and performance data and then compare it to pre-market data and report accordingly based on classification (i.e., #PSUR). #Vigilance is a reactive approach and part of the PMS. ☑️ #UDI - So you and others can uniquely track/trace your device in the market. ☑️ #EUDAMED - So you and other parties (economic operators, NBs, competent authorities, etc.) can obtain information on your device from a central location. ☑️ #AR - So you can have an #EU market #regulatory representation as a foreign manufacturer. ☑️ #Clinical Evaluation - So you can assess the clinical safety and performance of your device before certification. ☑️ #PMCF - So you can proactively assess the clinical safety and performance of your device and compare it to pre-market clinical evaluation. ❗️ ❕ ❓ ❔ Did I leave anything out? Please comment to expand or correct each item I have listed above. Thanks. ? Clarity from design to market™️ MedicalRegs ?