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
- Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
- FDA DRAFT GUIDANCE Electronic Submission Template for Medical Device De Novo Requests
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- Transição de ensaios clínicos para o Regulamento Europeu (complemento à Circular Informativa N.º 088/CD/100.20.200 de 04/09/2023)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Q&A ON TRANSITIONAL PROVISIONS FOR PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE COVERED BY ANNEX XVI OF THE MDR.
- European Commission Newsletter on medical devices | September 2023
- Good clinical practice (GCP) inspection procedures : ANNEX III TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: COMPUTER SYSTEMS