Consultant for Clinical Research with Medical Devices. Services offered in accordance with national and international regulations (e.g. GCP, ISO 14155, MEDDEV): Clinical investigational plan (protocol) development Patient informed consent development and review Site assessment Ethics Committee dossier preparation, submission, progress tracking Competent Authority dossier preparation, submission, progress tracking Investigational site initiation and training Field technical support for investigational device usage during study procedures Serious adverse event reporting to competent authorities for pre-market trials
Consultant for Clinical Research with Medical Devices. Services offered in accordance with national and international regulations (e.g. GCP, ISO 14155, MEDDEV): Clinical investigational plan (protocol) development Patient informed consent development and review Site assessment Ethics Committee dossier preparation, submission, progress tracking Competent Authority dossier preparation, submission, progress tracking Investigational site initiation and training Field technical support for investigational device usage during study procedures Serious adverse event reporting to competent authorities for pre-market trials