Regulation (EU) 2017/745 on Medical Devices (MDR) - TechFile Factory


NSF Prosystem offers its customers an extended service for technical documentation according to Regulation (EU) 2017/745, Annex I, II and III. The aim of this extended service is the cost- and time-optimized creation and maintenance of technical documentation in accordance with Regulation (EU) 2017/745 on medical devices using proven methods and documentation processes. To this end, we optimize existing concepts and processes, provide sufficient competent resources and establish new infrastructure, tools and processes as required. Our quality management system is certified according to ISO 13485 and 9001.
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