Officers and regulatory representatives of INTERVASCULAR SAS
FRAYSSE Laure
- conformity of devices is appropriately checked in accordance with QMS under which the devices are manufactured, before a device is released; -reporting obligations referred to in Art 87 to 91 are fulfilled; - technical documentation and EU DoC are drawn up and kept up-to-date; - PMS obligations are complied with in acc with Art 10; - in case of devices for performance studies, the statement referred to in Section 4.1 of Annex XV is issued.
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SAMACOITS Lucie
Deputy of PRRC when Laure Fraysse is absent, for the following responsabilities:
- technical documentation and EU DoC are drawn up and kept up-to-date;
- PMS obligations are complied with in acc with Art 10;
- in case of devices for performance studies, the statement referred to in Section 4.1 of Annex XV is issued.
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BLOUET Laure
Deputy of PRRC when Laure Fraysse is absent, for the following responsability:
- conformity of devices is appropriately checked in accordance with QMS under which the devices are manufactured, before a device is released.
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VANEENOGE Clémence
Deputy of PRRC when Laure Fraysse is absent, for the following responsabilities:
-reporting obligations referred to in Art 87 to 91
- PMS obligations are complied with in acc with Art 10.