Clinical Trials

• Clinical Trials for Medical DevicesClinical trials for medical devices are defined as “systematic research or studies conducted on volunteers at one or more centers to assess the Clinical Safety, Effectiveness, or Performance of the Medical Device.”

  Purpose of Clinical Trials:

  • To verify that the medical device meets the clinical performance targets set by the manufacturer,
  • To demonstrate that the device provides the expected clinical benefits to patients,
  • To identify any side effects under normal usage conditions and determine whether the device presents an acceptable risk to the patient when compared to the benefits it provides,
  • To discover new features of the medical device by using it outside of the intended use described in the device’s manual.

  Refer to the TİTCK Clinical Trials page for more details.

  https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihazda-klinik-arastirmalar