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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Compliance as a Business Advantage

    This session introduces the global regulatory landscape for medical devices and presents the areas health tech developers should focus on when bringing innovations to the markets. Basic terminology, classification rules, and the importance of a regulatory strategy and regulatory due diligence are presented.

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

    Topics

    • Global medical device regulations as your competitive advantage
    • Early focus of the health tech developer
      • Intended Purpose as the heart of your product
      • Is my product a medical device, and what is the risk class? Software, hardware, borderlines
      • What does the risk class tell me about my path to market?
      • How to save resources and time? Avoid re-inventing regulatory compliance
      • Your Regulatory Strategy for market entry
    • Align compliance with your business, marketing, and sales needs
      • General Safety and Performance Requirements at the heart of the regulation
      • Regulatory compliance in your Business Model and Value Proposition
      • The level of regulatory know-how in your business
      • Responsibilities and authorities within the business
      • Regulatory due diligence in investments, mergers & acquisitions – lessons learned

    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

    • Have the know-how to apply the correct regulations and standards to your innovation.
    • Understand the most crucial regulatory bottlenecks and typical pitfalls in the health tech business and time-to-market.
    • Recognize the value of understanding the regulatory essentials from early on.
    • Manage the basic terminology of the medical device regulations and standards.

    Additional information

    Combining this on-demand session with the Regulatory Essentials sessions 2, 3, and 4 is recommended.