Leica Biosystems Newcastle Ltd

Ensuring the conformity of devices is checked before release in accordance with the QMS under which the devices are manufactured; Ensuring technical documentation and the EU DoC are kept up-to-date; Ensure the PMS and vigilance reporting obligations are complied with; Investigational devices contain a signed statement required of Annex XIV Section 4.1 that the device conforms to GSPRs apart from the aspects covered by the performance study

Ensuring the conformity of devices is checked before release in accordance with the QMS under which the devices are manufactured; Ensuring technical documentation and the EU DoC are kept up-to-date; Ensure the PMS and vigilance reporting obligations are complied with; Investigational devices contain a signed statement required of Annex XIV Section 4.1 that the device conforms to GSPRs apart from the aspects covered by the performance study