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Iscriviti alla nostra newsletter per ricevere aggiornamenti sul mondo Farmaceutico e dei Dispositivi Medici

24 Novembre 2021

Quando condurre uno studio clinico con i dispositivi medici. Interazioni tra la ISO 14155 e il Regolamento (UE) 2017/745

10 Febbraio 2022

Good Distribution Practices

16 Febbraio 2022

Come applicare o implementare un sistema di gestione per la qualità secondo la norma ISO 13485:2016 tenendo conto del ruolo assunto nei confronti del prodotto

10 Marzo 2022

Dispositivi Medici a Base di Sostanze: applicazione dei requisiti della progettazione previsti dal Regolamento (UE) 2017/745 e integrazione con la ISO 13485:2016

Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. MDCG 2021-26

Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. MDCG 2021-25

Commissione Europea – Aggiornamenti sul sistema EUDAMED

Guidance on classification of medical devices. MDCG 2021-24

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