3D-Shaper Medical S.L.

• Agencia Española de Medicamentos y Productos Sanitarios
  SpainContact the authority →

No certificates registered for this manufacturer.

Devices placed in 1 country

• Spain3

4 contacts identified

• HL
  HUMBERT Ludovic

  PRRC
  View profile →
• IM
  IZQUIERDO María

  PRRC
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• HUMBERT Ludovic
  As substitute PRRC, he is responsible of performing the actions of the PRRC when the PRRC is not available.
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• IZQUIERDO María
  -Verification of the conformity of the manufactured devices in accordance with the quality management system before a device is released; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. -the post-market surveillance obligations are complied with in accordance with MDR. -the reporting obligations referred to Vigilance are fulfilled. -in case of investigational devices, the statement referred to in MDR is issued.
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• HUMBERT Ludovic — 3D-Shaper Medical
• IZQUIERDO María — 3D-Shaper Medical