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All services are provided according to applicable standards in clinical research industry:
GENERAL
Nuremberg Code
The Declaration of Helsinki
The Belmont Repot
FDA
FDA Federal Regulations on GCP and Clinical Trials
FDA Federal Regulation on Medical Devices
ICH
ICH Guideline on Good Clinical Practice (GCP) [E6]
ICH Efficacy Guidelines
ICH Safety Guidelines
ICH Quality Guidelines
ICH Good Manufacturing Practice Guideline (GMP) [Q7]
ICH Multidisciplinary Guidelines
ISRAEL
Israeli MoH Guideline on Human Clinical Trials (2014)
Israeli MoH Guideline on Adverse Events and New Safety Information Reporting
MEDDEV
MEDDEV Guidelines on Clinical Investigations of Medical Devices
MEDDEV Guidelines on Clinical Evaluation of Medical Devices
MEDDEV Guideline on Classification of Medical Devices
MEDDEV Guideline on Post Market Clinical Follow Up Studies
MEDDEV Guideline on the Medical Device Vigilance System