Activity

  • andria93 replied to the topic RECALLS in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago

    I think it is like other devices that can have a recall for corrective actions, but when we talk about medical devices it is more sensitive as it could cause life-threatening. The human body could have a different reaction to any implementation or even procedures. So Even FDA approve it and companies do research and test. It’s still possible that it’s not going to work 100% on everyone. I think that’s why most doctors make patient sign the consent about side effect or complications after for such operations. So I believe even FDA approved, Thier, is no guaranty until they try and it might not work for everybody. We talked last week about the difference of time for research companies talk vs academia, and believe they issues happen when companies rush to roll out a product without the prober trials and clinical studies.