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Safety reporting for clinical investigations under the MDR
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
IVD Clinical Performance Studies
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
List of Member States’ Competent Authorities for Medical Devices
The competent authorities are responsible for transposing the requirements of European regulations into national legislation. The competent
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