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    Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

    This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting. Developing a Global Strategy for Early Consultations Are you developing an innovative medical device? Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/...