Safety certification for medical device embedded software



Neto, J.A., Figueiredo Damásio, J., Monthaler, P. and Morais, M. (2015) Product-based Safety Certification for Medical Devices Embedded Software. Studies in Health Technology and Informatics. 216, p.227-31.


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 regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

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