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    Digital Health, AI, and Software:
    Lean Regulatory Market Access Now
    and in the Future

    Rudolf Wagner, CEO at ADHOCON

    In the fast-paced world of digital health, regulatory compliance is critical—but it doesn’t have to be a bottleneck. Rudolf Wagner shared practical strategies for achieving lean regulatory market access in an increasingly complex landscape.

     

     

    Key takeaways:

    • Harmonized standards: The IMDRF’s alignment of FDA and EU standards simplifies global market entry.
    • Lean compliance: Build only what’s necessary, starting with an ISO 13485-aligned QMS.
    • Now is the time to act: Today’s lenient regulations won’t last forever—companies that adapt early gain a competitive edge.

     

    Compliance, Wagner emphasized, isn’t just about meeting requirements—it’s about building trust with hospitals, insurers, and patients.


    Watch the webinar to learn how to make compliance a strategic advantage in digital health innovation.