Stryker Neurovascular

Ensure that the technical documentation and the EU DoC are drawn up and kept up to date in accordance with EU MDR. Ensure that PRRCs with the following responsibilities are identified: That the conformity of devices is in accordance with the QMS under which the device is manufactured before the device is released into the EU market. That PMS obligations are complied with and that the reporting of serious incidents and field safety corrective actions are in accordance with EU MDR.

That the conformity of devices is in accordance with the QMS under which the device is manufactured before the device is released into the EU market.

That the conformity of devices is in accordance with the QMS under which the device is manufactured before the device is released into the EU market.

Ensuring that PMS obligations are complied with and that the reporting of serious incidents and field safety corrective actions are in accordance with EU MDR.