Berlin, Germany
Core Topics EU-Level: #EU-MDR state of play and future of the regulatory system in europe #Medical Device Labelling, Qualitymanagement, PRRC, Clinical investigation & evaluation, Standardization #Interplay of AI-Act and Medical Device Regulation Core Topics Germany: #Medizinforschungsgesetz #Medizinprodukterecht-Durchführungsgesetz Special Interest Topics: #Supplier for medical devices
#1 making sure (in process and design) that package labelling is in compliance with standards, marketing wishes and world wide regulatory requirements; #2 to set up reliable processes and structures so that "what comes in the box" is what the customer wants, needs and is allowed to get; #3 all medical device risk classes, all countries, active implants, external devices, accessories, cables, sw-md's, graphics, symbols, barcodes, implant card, ifu, eifu, customs stickers, etc.