QbD Group
    点播网络研讨会

    Getting Started

    Overcoming Initial Obstacles in Medical Device Software Development

    Watch our webinar where we address major challenges in software qualification and classification for different functionalities. We explore MDR for software-hardware combinations and how AI is handled under the AI Act. In addition, we share essential resources, key standards, and guidance documents crucial for getting your product to market, from design and development to clinical evidence and technical documentation.

    随时观看
    60 分钟
    Software Solutions & Services · Medical Devices
    Chinese

    ntation.

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    What you'll learn

    • Regulatory requirements for MDSW.
    • Classification impact on development and documentation.
    • How MDR and AI Act apply to software.
    • Best practices for standards and guidance documents.
    • Connections between market access, design, clinical evidence, and technical documentation.

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    演讲者

    Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.

    Caroline Aernouts

    Caroline Aernouts

    Senior Consultant RA MD

    With 3 years at the QbD Group as consultant in Regulatory Affairs for medical devices, Caroline’s main expertise lies in Medical Devise Software (MDSW). Before this, she spent 5 years at Materialise, focusing on MDSW and CM implants.
    Pieter Smits

    Pieter Smits

    SaMD expert & Project manager

    Pieter is a seasoned SaMD/MDSW expert with extensive experience in EU and US regulations and standards, especially in AI and cybersecurity regulatory requirements. His expertise covers compliance with regulations like MDR/IVDR and FDA legislation, alongside standards such as ISO 13485, IEC 62304, IEC 82304, ISO 62366, ISO 81001, and ISO 14971. In addition to his technical expertise, Pieter brings valuable project management experience in the pharmaceutical and medical device industries, helping organizations solve complex problems and implement effective solutions to achieve their goals. Pieter’s Mission: To prove that compliance and innovation can go hand in hand while staying at the forefront of the evolving landscape of SaMD/MDSW legislation and standards _._

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