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.
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- Study supporting the monitoring of the availability of medical devices on the EU market
- Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams
- Iniciativa para melhorar a eficiência na aprovação de novos medicamentos na UE
- Consulta pública a decorrer para Projeto de Regulamento de Execução sobre consultas científicas conjuntas de medicamentos
- EUDAMED user guide Guidelines on Data Exchange with EUDAMED
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
- Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
- Guidance for best practices for clinical trials