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Software quality regulation under the Safe Medical Devices Act of 1990: hospitals are now the canaries in the software mine.
The 1990 Medical Device Amendments to the Food and Drug Act have caused a significant change in the regulation of medical software. The 1990 Act replaces the prior emphasis on premarket approvals with an emphasis on postmarket surveillance. Hospitals and other institutional users are now required to...
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Medical Informatics Association
1991
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2247531/ https://ncbi.nlm.nih.gov/pubmed/1807596 |
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