Robert Speer, Dipl. Ing Medizintechnik Consultant Medical Devices EMEA Professional Experience (abstract) NSF PROSYSTEM GmbH Consultant for regulatory affairs and project management for the medical device industry Assessment and preparation of technical documentation as per EU Medical Device Regulation (MDR) 2017/745 10 years of working experience in the area of Assessment and preparation of Technical Documentation as per EU MDR, Annex II Risk Management as per ISO 14971 Usability assessment as per IEC 62366-1 Biological safety evaluation as per ISO 10993-1 EU-MDR implementation projects 510(k) submission (FDA market clearance) 5 years of indutry experience R&D, manufacturer of trauma implants