Ensuring
-Technical documentation and EU DOC are drawn up and kept up-to-date.
-Reporting obligations are fulfilled.
-For investigational devices, a signed statement is issued, stating the device conforms to the GSPRs apart from aspects covered by the clinical investigation, and every precaution has been taken to protect health & safety of the subject.
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PERRUZZA Larry
Ensuring
-Conformity of the devices is appropriately checked before device release.
-Technical documentation and EU DOC are drawn up and kept up-to-date.
-PMS obligations are complied with.
-Reporting obligations are fulfilled.
-For investigational devices, a signed statement is issued, stating the device conforms to the GSPRs apart from aspects covered by the clinical investigation, and every precaution has been taken to protect health & safety of the subject.
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PATEL Nirali
Ensuring
-Conformity of the devices is appropriately checked before device release.
-PMS obligations are complied with.
-Reporting obligations are fulfilled.