Requirements for clinical evidence of medical device safety and performance are increasing globally. Not only in Europe, but in Australia and the United States. For devices that have already been on the market in the United States, you may have an option you hadn’t thought of: a retrospective observational research study. This option is particularly useful for implants, but can be used for any medical device used by or prescribed by a clinician in the United States. Simply put, you can tap into existing medical records to gather sufficient clinical evidence of the safety and efficacy of your device. You just have to make sure you do it the right way.
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