Post-market interventional clinical investigations are the most robust, and often the costliest approach to collecting data for the ongoing surveillance of clinical benefits, performance, and safety of medical devices after market release. However, the value of a well-designed PMCF interventional clinical investigation may extend beyond regulatory compliance to include scientific and commercial objectives that support the long-term success of a device and can be a logical choice to collect clinical data as part of a wider Post Market Surveillance cycle. In this guide, we explore strategic planning considerations for post-market interventional clinical investigations and offer tips for designing, developing, and conducting successful studies.
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