A Comissão Europeia publica um guia passo a passo com o Modelo para a implementação do Regulamento relativo aos Dispositivos Médicos
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- IMDRF Document Implementation Report
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- FDA final guidance on ‘Electronic Submission Template for Medical Device De Novo Requests’
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- ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module