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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Early Development and Management

    This session wraps up the must-know issues to consider in the early development of your innovation. How to demonstrate compliance with applicable regulations and build up a Quality Management System (QMS) that ensures that devices consistently meet the requirements for safety and performance?

    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

    • Early development stages
      • Timelines and the Medical Device Life Cycle
      • Capturing the Value Proposition
      • Early validation through Feasibility Studies
      • Preparing for Design Control and Post-Market activities
      • Assigning roles and responsibilities in-house and externally
      • Document and records management, logs, and traceability
    • Building your Quality Management System (QMS)
      • ISO 13485 and other international QMS-related standards
      • Management responsibility
      • From planning to operations – Ensuring consistently safe and efficient devices
      • Supplier Control – From supplier evaluation to contracts and partnership
      • Importer and Distributor relations

    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

    • Know what to take into account regarding regulations and standards from the early stage of product development
    • Have a view of the medical device life cycle from early development to post-market actions
    • Know what to consider when planning your Quality Management System (QMS)

    Additional information

    Combining this on-demand session with the Regulatory Essentials sessions 1, 3, and 4 is recommended. For a more specific knowledge and hands-on approach to ISO 13485 and QMS requirements, it is recommended to follow a one-day ISO 13485 -course.