Product-based Safety Certification for Medical Devices Embedded Software.
PMID: 26262044 ·
José Augusto Neto, Jemerson Figueiredo Damásio, Paul Monthaler, Misael Morais
JournalStudies in health technology and informatics
Year
PMID26262044
Abstract
Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulato
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