REFERÊNCIAS:
.-EMA: Questions and answers: Good manufacturing practice – Data Integrity Section
.-FDA: FDA Data Integrity Guidance
.-MHRA: MHRA Data Integrity Definitions and Guidance
.-PIC/S: PIC/S Guidance
.-WHO: WHO Guidance
Artigos recentes
- New liability rules on products and AI to protect consumers and foster innovation
- FDA GUIDANCE DOCUMENT : Clinical Decision Support Software
- FDA NEW GUIDANCE : Policy for Device Software Functions and Mobile Medical Applications
- Team-NB Position Paper on Hybrid Audit
- KPGM INSIGHTS : Medical devices 2030
- Electronic Submission Template for Medical Device 510(k) Submissions
- Fabrico de medicamentos estéreis: publicação da nova versão do Anexo 1 do Guia das Boas Práticas de Fabrico
- MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD