The PRRC ensures device conformity per the QMS (Article 10(9)), maintains technical documentation and the EU Declaration of Conformity, and oversees PMS and vigilance reporting. They ensure compliance with MDR and GSPR and, when required, support clinical evaluations and performance studies.
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SINGH Abhinay
The PRRC ensures device conformity per the QMS (Article 10(9)), maintains technical documentation and the EU Declaration of Conformity, and oversees PMS and vigilance reporting. They ensure compliance with MDR and GSPR and, when required, support clinical evaluations and performance studies.
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GUPTA Amit
The PRRC ensures device conformity per the QMS (Article 10(9)), maintains technical documentation and the EU Declaration of Conformity, and oversees PMS and vigilance reporting. They ensure compliance with MDR and GSPR and, when required, support clinical evaluations and performance studies.