An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020.
- Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- Gestão de Risco no âmbito das Boas Práticas de Distribuição : “Formação muito bem conseguida com aplicabilidade prática”
- EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME : Audit Checklist
- MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
- Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
- Artificial Intelligence in Drug Manufacturing.
- Guideline on computerised systems and electronic data in clinical trials
- PROMOTIONAL REVIEW de DISPOSITIVOS MÉDICOS : “Sem dúvida um evento enriquecedor”