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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Design Control and the Regulatory Environment

    This session reviews the principles of Design Control, starting from feasibility studies to Post-Market Surveillance. A brief look at the roles of the key authorities, certifiers, and test laboratories overseeing devices and manufacturers is also given.

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

    Topics

    • Introduction to Design Control
      • From Feasibility Studies to Post-Market Surveillance
      • Design Verification and Validation
      • Transfer to production
    • Authorities, Notified Bodies, and test labs
      • Towards certification – CE-mark, FDA approval, and global market access
      • The perspective of authorities globally
      • Auditing and certification practices
      • Communicating with the authorities
    • Considerations on the Changing Global Regulations
      • Navigating the transitional periods
      • From the current EU directives to new regulations – MDR & IVDR
      • Strategies for dealing with a variety of requirements and timelines

    Target group

    All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of health tech innovations and to avoid typical dead-ends due to non-compliance to the medical device or in vitro diagnostic 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

    • Will know how to control the design according to the global requirements throughout the device life cycle
    • Will understand the changing regulatory landscape, the mindset of the authorities, and the market access mechanisms in significant markets globally

    Additional information

    Combining this on-demand session with the Regulatory Essentials sessions 1, 2, and 3 is recommended.