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Chaves para a conformidade médica
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ISBN10: 6209455980
ISBN13: 9786209455988
Publisher: Edicoes Nosso Conhecimento
Published: Dec 30 2025
Pages: 108
Weight: 0.34
Height: 0.26 Width: 6.00 Depth: 9.00
Language: Portuguese
ISBN13: 9786209455988
Publisher: Edicoes Nosso Conhecimento
Published: Dec 30 2025
Pages: 108
Weight: 0.34
Height: 0.26 Width: 6.00 Depth: 9.00
Language: Portuguese
Resumo - Volume IChaves para a conformidade médica: da ideia ao lançamento no mercado global é um guia conciso e acessÃvel para compreender como uma inovação médica se torna um dispositivo seguro e de alto desempenho que cumpre os requisitos internacionais.O livro apresenta as principais normas - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - e explica o seu papel na qualidade, gestão de riscos, biocompatibilidade, fabrico de aditivos, cibersegurança e rastreabilidade.Recorrendo a exemplos concretos (implantes, instrumentos cirúrgicos, software médico, salas limpas, scanners), traça as etapas essenciais da conformidade: conceção, validação, ensaios, controlo de qualidade, gestão de documentos e certificação.O livro também destaca a contribuição da inteligência artificial para o controlo regulamentar, a garantia de qualidade e a cibersegurança.Através das suas publicações, o autor oferece apoio prático a estudantes, investigadores e industriais e inspira uma nova geração a encarar a conformidade não como um constrangimento, mas como uma verdadeira alavanca para a inovação, a segurança e a competitividade global.
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