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Stud Health Technol Inform · Jan 2015
Product-based Safety Certification for Medical Devices Embedded Software.
- José Augusto Neto, Jemerson Figueiredo Damásio, Paul Monthaler, and Misael Morais.
- State University of Paraíba - UEPB, Campina Grande, Paraïba, Brazil.
- Stud Health Technol Inform. 2015 Jan 1; 216: 227-31.
AbstractWorldwide 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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