Project Coordinator - Health Care Products
Coordination on the development of medical devices for cardiological use.Product Certification and CE Mark. MDR regulation. Local and international regulatory affairs. Product technical file.Quality Management system under ISO 13485-2016, with area procedure and work instructions. Risk Management under ISO 14971:2019Manufacturing good practice under ANVISA RDC-16/2013.Medical devices safety and performance requirements under 60601 series and software lifecycle according to ISO 62304.