Activity

  • neb2 started the topic Significant risk vs Non-significant Risk in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

    During lecture, Dr. Simon explained that clinical trials are classified as significant risk or non-significant risk. The level of risk is determined by how much harm the subject could acquire from the study. Significant risk (SR) is a study that that presents potential for serious risk to health, safety, or welfare of subject (like implants), while non-significant risk (NSR) is a study that does not meet the definition of the significant risk.
    From your point of view, knowledge or experience in the industry, can you provide examples of devices the are classified as NSR or SR?