Description: The FDA consensus and EU harmonized ISO 14155:2020 was developed initially to support clinical activities in the changing regulatory landscape of the European Union (EU). The standard was later accepted as a consensus standard by the FDA. The newer version of the standard is much more comprehensive and includes new aspects to clinical investigations, such as the implementation of a dedicated quality system and utilization of the ISO 14971 standard for risks management. The basics of Good Clinical Practices (GCP) have been added to the standard. If followed in full compliance, this standard is an excellent guideline for creating a safe and successful clinical investigation to support both regulatory submissions and post market clinical requirements. This session will demonstrate the vast differences between the newer and old (2011) standard for clinical investigations in human subjects with medical devices and provide insight into using this standard as the basis for study planning.
Learning Objectives:
Upon completion, participants will be able to better understand newer requirements set forth in the ISO 14155:2020 standard, which meets the clinical requirements both in the USA and EU
Upon completion, participants will be able to better understand the broader implications of following Good Clinical Practices for their clinical investigations.
Upon completion, participants will be able to create a full and comprehensive clinical investigation plan (protocol)/report as well as create the necessary documents for regulatory authorization of their clinical investigations.