Product-based Safety Certification for Medical Devices Embedded Software.
Stud Health Technol Inform
; 216: 227-31, 2015.
Article
em En
| MEDLINE
| ID: mdl-26262044
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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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Software
/
Certificação
/
Aprovação de Equipamentos
/
Regulamentação Governamental
/
Equipamentos e Provisões
Tipo de estudo:
Guideline
/
Prognostic_studies
País/Região como assunto:
America do sul
/
Brasil
Idioma:
En
Revista:
Stud Health Technol Inform
Assunto da revista:
INFORMATICA MEDICA
/
PESQUISA EM SERVICOS DE SAUDE
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Holanda