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Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in the US and EU

Post thumbnail Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in the US and EU

Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space of imaging and treatment planning. At the same time, the medical device industry and regulations were still viewing this space as mostly hardware-centric; therefore, the evolution and understanding of the design, development and commercialization needs of standalone software devices were not very appropriately covered in the regulatory regime.

Significant technological advancements (e.g. the AI boom), the COVID-19 pandemic and increasing time and resource pressures in healthcare systems have accelerated the development of digital applications to aid data management, reduce human bias, and improve disease diagnosis, treatment, and prevention. This has pushed regulators to accelerate the development of supporting mechanisms (via regulation, guidance or special programs) for such innovative and much-needed software.

Most eyes are on how key markets, such as the EU and the US, are looking to ensure the public benefits from innovative SaMD products that are both appropriately assessed and can reach their intended users fast enough. At the same time, they are also allowed to evolve at a good pace.

In this Ask the Experts session, we answered questions concerning topics such as:

  • Which questions should one be able to answer in order to decide whether to enter the EU or the US first with their SaMD?
  • How can a CE-marked SaMD capitalize on its data to accelerate US market entry and vice versa?
  • Which programs (i.e. Regulatory Bodies consultations, “Fast Track” for innovative devices, etc.) and regulatory paths can SaMD developers/manufacturers benefit from in the US and the EU?

Download: Answers to the key questions

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    Featured Speakers

    Michael Husband, M.Sc. thumbnail
    Michael Husband, M.Sc.
    Director, Medical Devices and Combination Products
    Michael is a proven expert in the areas of FDA marketing applications for highly innovative Medtech and Digital HealthTech products. He has more than 20 years of experience in the United States Federal Government including FDA, BARDA, and DoD encompassing advanced clinical decision support software, connected devices and digital monitoring systems. Based on his technical and FDA background, Michael successfully bridges the gap between scientists, Medtech engineers, and US MD regulators.
    Andromachi Kaltampani, M.Eng, M.Sc. thumbnail
    Andromachi Kaltampani, M.Eng, M.Sc.
    Director, Medical Devices
    Andromachi holds over 10 years of experience in the medical devices industry, working with active device manufacturers of different regulatory maturity and product risk profile with particular focus on software devices. She has worked with regulators in Europe and North America. She has been instrumental in the transition of Technical Files from MDD to MDR, along with SaMD product up-classification. Finally, she has also developed expertise in topics including, QMS development, implementation, certification and remediation.
    Christophe Amiel, M.Sc. thumbnail
    Christophe Amiel, M.Sc.
    Senior Director, Medical Devices & Digital Life Science
    Christophe is an accomplished HealTech professional with more than 25 years of experience in regulatory science from concept to market in start-up and international company environment. He has assisted more than 300 Medtech/Digital companies for placing on EU and US markets of their disruptive technologies by establishing and implementing their regulatory strategies for their disruptive health technologies including AI/ML based SaMD, Expert Systems, Connected Devices, Drug delivery systems and Digital biomarkers