Product-based Safety Certification for Medical Devices Embedded Software.
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).
State University of Paraíba - UEPB, Campina Grande, Paraïba, Brazil.
José Augusto
JA
Neto
State University of Paraíba - UEPB, Campina Grande, Paraïba, Brazil.
Jemerson
J
Figueiredo Damásio
State University of Paraíba - UEPB, Campina Grande, Paraïba, Brazil.
Paul
P
Monthaler
State University of Paraíba - UEPB, Campina Grande, Paraïba, Brazil.
Misael
M
Morais
D001938:Brazil; D002568:Certification / Q000458:organization & administration*; D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D012984:Software / Q000592:standards*