Dirigeants et représentants réglementaires de Elbnova GmbH
EBRAHIM KANI Ehsan
1.Ensure product compliance with the quality system before market release.
2.Maintain and update technical documentation and EU Declaration of Conformity.
3.Oversee post-market surveillance (PMS) and related reports.
4.Ensure proper incident and FSCA reporting to authorities.
5.Monitor regulatory changes and update internal processes accordingly.
6.Act as the main contact for regulatory authorities and Notified Bodies.
7.Ensure staff are trained and aware of applicable regulatory requirements.