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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Regulatory Essentials of In Vitro Diagnostics

    This on-demand session is dedicated to essentials for IVD developers, presenting the most critical IVD standards, IVD risk classes, and regulatory strategies for market entry. Some other IVD specifics are also presented, such as compiling General Safety and Performance Requirements for IVDs and Performance evaluations.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics

    • The early focus of the IVD developer
      • Is my product or software an IVD, and what is the risk class?
      • What does the risk class tell me about my path to market?
      • A glance at the most critical IVD standards
      • Your Regulatory Strategy for Market Entry
    • Other IVD specifics
      • General Safety and Performance Requirements for IVDs
      • Quality management for IVDs – What to consider?
      • Performance evaluations – What data do you need, and what sources can you use?
      • Special Risk Management Considerations for IVDs

    Target group

    All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of in vitro diagnostic (IVD) innovations and to avoid typical dead-ends due to non-compliance to IVD regulations. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, business advisors, and investors from early seed development to international scaling.

    Objectives

    • Know the regulatory specifics related to in vitro diagnostics (IVD)
    • Have the know-how to apply the correct IVD regulations and standards to your innovation
    • Understand the most crucial regulatory bottlenecks and typical pitfalls in IVD business and time-to-market
    • Manage the basic terminology of the IVD regulations and standards

    Additional information

    Following the Regulatory Essentials sessions 1-4 before this on-demand session is recommended.