Podcast · Episode 76

    Building Medical Devices Right the First Time with Helen Souris

    With Helen Souris

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    Episode 76: Building Medical Devices Right the First Time with Helen Souris

    Listen to episode 76

    Episode summary

    Helen Souris shares lessons from leading a digital therapeutics company and supporting Australia's medical technology sector. She explains why regulatory strategy, quality systems, cybersecurity, and commercial planning need attention early, before growth exposes expensive gaps in the business.

    Key points

    • Digital therapeutics and software regulation
    • Cybersecurity in procurement decisions
    • Early quality management planning

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