NSF PROSYSTEM GmbH, is a worldwide leading consulting and service company in biomedical engineering. The sustainability of our successful projects is the foundation of our longstanding customer relationships. Together with our customers we form the future of biomedical engineering by pointing out new chances as well as handling critical challenges. Our portfolio covers consulting, management of complex projects and interim management. It is our business to meet your special needs and to offer ideal solutions.
PROSYSTEM is working as an active member in standardization groups like for example: ISO 13485, ISO 14971, IEC 62366, IEC 60601 and IEC 62304/82304. Therefore we have influence on standardization politics and decisions. By co-creating standards we are able to strengthen your company’s position against the competition.
Company’s Keywords:
medical devices, consulting, regulatory affairs, quality management, clinical evaluation, clinical investigation, project management, crisis management, medical device regulation 2017, 745, invitro diagnostic regulation 2017, 746, postmarket surveillance, technical documentation, clinical trials, ivdr, eu mdr
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